New data demonstrate that maintenance therapy with RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) significantly delayed the time to relapse compared to placebo in patients with Bipolar I Disorder. Results of the study were presented this week at a major medical meeting.

Bipolar Disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the American adult population in any given year.

A randomized, double-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study, 303 patients were stabilized on open-label RISPERDAL(R) CONSTA(R) for 26 weeks. In the double-blind phase, patients were randomized to either maintenance therapy with RISPERDAL(R) CONSTA(R) (N=154) or placebo (N=149). The median duration of treatment was nine months for patients in the RISPERDAL(R) CONSTA(R) group and five months for patients in the placebo group. The primary endpoint was time to relapse of any mood episode (depression, mania, or mixed).

Time to relapse was significantly longer in patients receiving RISPERDAL(R) CONSTA(R) monotherapy as compared to placebo (p<0.001). In addition, the rate of relapse during the double-blind treatment phase was lower among patients in the RISPERDAL(R) CONSTA(R) group (30 percent; 42/140) compared with the placebo group (56 percent; 76/135). The median dose of RISPERDAL(R) CONSTA(R) was 25 mg.

The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy).

“This is the first randomized controlled study to demonstrate the efficacy of RLAT as a maintenance therapy in patients with Bipolar Disorder,” said Joseph Palumbo, M.D., Franchise Medical Leader, Psychiatry, Central Nervous System and Pain Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD). “These findings are important because the clinical course of Bipolar Disorder is often unpredictable and relapses can be very debilitating.”

The study was presented and sponsored by Janssen, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and J&JPRD.

About RISPERDAL(R) CONSTA(R) Long Acting Treatment

RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) is a long-acting injectable atypical antipsychotic therapy used for the treatment of schizophrenia and the maintenance treatment of Bipolar I Disorder. It was developed utilizing Alkermes’ proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RISPERDAL(R) CONSTA(R) is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.

About Janssen

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently has prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder.

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.

IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL(R) CONSTA(R) and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL(R) CONSTA(R). Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDAL(R) CONSTA(R) and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL(R) CONSTA(R) may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

Problems with the blood have been reported with RISPERDAL(R) CONSTA(R) and similar medications. Depending upon condition your doctor may choose to monitor your blood as you start therapy with RISPERDAL(R) CONSTA.

RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long lasting erections have been reported with the use of RISPERDAL(R) CONSTA(R). Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when administering RISPERDAL(R) CONSTA(R) to a nursing woman.

RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R).

In a study of people taking RISPERDAL(R) CONSTA(R), the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In a study of people taking RISPERDAL CONSTA, the most common side effects in the treatment of Bipolar I Disorder were weight gain (when used alone) and tremors (when used with other medications).

If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor.

IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.

Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely.

Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

Priapism has been reported. Severe priapism may require surgical intervention.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported.

Administration: Care should be taken to avoid inadvertent injection into a blood vessel.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.

Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.

Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease)

Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%).

– Akathisia and restlessness

– Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia

Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R).

Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.

Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.

The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial).

Source: Janssen

View drug information on Risperdal Oral Formulation.

Posted in: Bipolar Disorder, Prescription Bipolar Drugs Comments (1)

Prepared Patient: Managing Mental And Medical Illness

Posted by admin on May 22nd, 2009

22
May

In her 1984 boot camp graduation photo, Adrienne Fitts is smiling. Her hair is neatly groomed, her Navy cap and dress whites are spotless and she is regulation fit and trim.

Flash forward to 2001. Fitts, now a retired Gulf War veteran, struggles with a mental illness called schizoaffective disorder. She is 90 pounds heavier and has developed type 2 diabetes. She is certain her regimen of antipsychotic drugs (”there are so many”) caused the diabetes as well as high blood pressure.

In April 2006, Adrienne Fitts suffers a stroke.

And there’s Gloria, a 56-year-old legislative advocacy worker, who also deals with both a major mental and medical condition. Gloria,has long-term clinical depression, neurological problems and on top of that, partial kidney failure.

“Multiple conditions are not rare and they become even more common as people get older,” says Dennis Freeman, Ph.D., the CEO of Cherokee Health Systems in Tennessee.

“Twenty-five percent of people in a primary care practice have a psychiatric illness,” says Wayne Katon, M.D., vice chair of the department of psychiatry and behavioral science at the University of Washington School of Medicine.

Children are vulnerable, too. “Kids with anxiety and depressive disorder,” Katon says. “This makes more of an impact on school performance and the ability to make and keep friends. Parents and schools have to be especially watchful for the additive effects of having two conditions.”

For many people, physical conditions can contribute to problems with their mental health problems that are often ignored and untreated. But your emotional health and physical health affect each other. Here’s what you should know.

The stakes are high.

When recovering from a heart attack, it’s natural to be focused on your physical recovery rather than your state of mind, but the two are intertwined, says Eric Goplerud, Ph.D.

“A heart attack produces large amounts of cortisol that precipitates depression,” explains Goplerud, the director of the Center for Integrated Behavioral Health Policy at George Washington University Medical Center.

“At least twenty percent with heart attacks have severe depression and these people are three times more likely to die if the depression is not dealt with promptly,” he says.

“People who have mental problems often have other health problems and they come together in legion,” Goplerud says.

Drugs that help your mind can harm your body.

In a health care Catch-22, the same drugs that help people manage bipolar disorder, schizophrenia and depression can have serious physical side effects.

As part of her treatment, Fitts has received some heavy-duty drugs, including olanzapine.

“Clozapine and olanzapine are the two antipsychotic drugs that the American Diabetes Association found the highest risk of causing weight gain and poor lipid control.” Goplerud says. As for drugs to combat depression, “some SSRIs are associated with weight gain and may contribute to diabetes. So you may be developing life-threatening illnesses from appropriate treatment of your mental illness.”

The dilemma works both ways, Goplerud adds: “Sometimes treatment we prescribe for in medical care end up causing mental health problems.” For instance, “People who have been legitimately prescribed powerful pain meds can become addicted.”

If you are ever prescribed antidepressants, or given medication to help you sleep, doses often need to be fine-tuned and you might need to try several drugs before to find one that works for you. Although primary care practitioners or clinic doctors can prescribe these drugs, follow-up can fall through the cracks. Let someone know if your treatment isn’t helping.

Patients have options, Goplerud says. “Talk to your physician about other medicines that might be used.”

Speaking up is vital to your mental health.

Fear of the stigma of mental illness can keep patients from speaking up, says Chris Koyanagi, policy director of the Bazelon Center for Mental Health Law. Some “are reluctant to tell primary care doctors about their psychiatric medicines: ‘I just don’t want my regular doctor to know.’”

Recalls Gloria: “As a teenager I had aches and pains and my parents took me to the Mayo clinic. They wanted me to see a psychiatrist. My father said fine, as long as they could come with me. The psychiatrist asked, ‘Are you depressed?’ Dad answered, ‘No, she’s not.’”

Meanwhile, physical conditions arose that could not be brushed aside. It was only years later, when she had an emotional collapse on the job that Gloria began treatment for depression.

Your health care is usually scattered across different settings.

“Health systems are fragmented, people are integrated,” says Dennis Freeman, Ph.D., the CEO of Cherokee Health Systems in Tennessee.

People are often are forced to work with an array of health care providers. “It’s daunting to go to three different clinics; it’s hard for anyone,” Katon says. “Fragmentation is even worse for people with mental health issues.”

Dangerous drug interactions are possible when no single health professional has a handle on all the medications you take: you could receive heart pills from one doctor and an antidepressant from another doctor without either being aware of what the other prescribes.

“At the least, one single person or entity needs to know all the medications you take and all the diagnoses you have,” Koyanagi says. “This can be your primary care physician, your mental health practitioner, your pharmacist.”

Some mental health care is “nested” with medical care.

Katon, who brings his psychiatric expertise to a medical practice one day a week, says, “It’s ideal if psychiatric care can be merged into medical care,”
“We found that mental health care programs with primary care onsite sometimes provided by a nurse practitioner or physician assistant who can do regular and effective screens, can link people to community services [work best],” Koyanagi agrees.

Federally qualified health centers, like Freeman’s Cherokee Health System in Tennessee, provide a full range of services from professionals who communicate daily with one another and have access to a single, unified medical record for each patient.

Unfortunately, it can be hard to find mental health care at all, much less integrated medical-mental care. “Half of counties in the United States don’t have mental health providers,” Freeman says.

In those areas, “You probably go to a primary care physician. They will do the very best they can. They’re not psychotherapists or behaviorists, but psychiatrists are in short supply every place, even among insured,” he says. “So you go to see your primary care physician, talk to your minister, if you’re in school it may be your teacher and guidance counselor.”

We’re all vulnerable at various times in our lives.

Just as we have ups and downs of physical health, everyone also deals with challenges that affect our moods and stability. It helps to know your baseline: What’s your usual mental state? How do you know when things are out of control?

“We all have times we’re not as resilient and not managing as well,” Freeman says. “That’s when the team needs to support you, help you through the rough times.”

You might need additional support, not only from mental health professionals but also the people in your life. Sharing confidences and concerns with trusted friends and family or joining a support group can help restore your mental balance.

Fitts has found and given support through the Depression and Bipolar Support Alliance, a peer group for people with mood disorders. Earlier, when she developed substance abuse issues which often go along with mental illness and can complicate medical treatment she looked outside herself for help. “I just made some decisions. It’s a process. I use a 12-step approach. I have a group in my church. It’s helped me to get my thoughts together.”

If you’ve been diagnosed with a medical illness and you don’t feel right emotionally: “Talk to your physician, tell your nurse.” Goplerud says. “Misery is not necessary. You don’t have to live with feeling physically miserable or mentally miserable.”

Source: Health Behavior News Service

Posted in: Bipolar Disorder, Prescription Bipolar Drugs Comments (0)

FDA Grants Approval For Use Of RISPERDAL(R) CONSTA(R) As Both A Monotherapy And Adjunctive Therapy In The Maintenance Treatment Of Bipolar I Disorder

Posted by admin on May 19th, 2009

19
May

Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder.

Bipolar Disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately 1 percent of the American adult population in any given year.

“Long-acting therapies are moving to the forefront of treatment for mental illness, and the approval of risperidone long-acting treatment for Bipolar Disorder is exciting because it offers physicians assurance that the medication is being taken as prescribed,” said Caleb Adler, M.D., principal investigator and associate professor of Clinical Psychiatry at the University of Cincinnati. “Further the bi-weekly administration schedule encourages regular contact between patients and their treatment team.”

The approval is based on two prospective, randomized, double-blind, placebo-controlled studies for the long-term treatment of Bipolar I Disorder. The first demonstrated that RISPERDAL(R) CONSTA(R), when used as a monotherapy, was significantly better than placebo at delaying the time to relapse of any mood episode. The second study demonstrated that, for patients already taking lithium or valproate, the addition of RISPERDAL(R) CONSTA(R) significantly delayed the time to relapse compared to current treatments plus placebo.

“We are very pleased with this FDA approval for RISPERDAL(R) CONSTA(R),” said Husseini Manji, M.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research and Development. “We are committed to creating new, long-acting therapies that offer safe and effective products for treating patients with mental illnesses. This approval provides physicians and patients with a new treatment option that offers a convenient and effective choice to delay relapse.”

RISPERDAL(R) CONSTA(R) was approved in 2003 as an atypical antipsychotic agent indicated for the treatment of schizophrenia and is now the first and only long-acting injectable antipsychotic therapy available for the treatment of schizophrenia and Bipolar I Disorder.

About RISPERDAL(R) CONSTA(R)

Risperidone long-acting treatment (RLAT) is a long-acting injectable form of risperidone that was developed utilizing Alkermes’ proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RLAT is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a member of the Johnson & Johnson family of companies, the world’s most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.

About Janssen

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies.

IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)

RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when RISPERDAL(R) CONSTA(R) is administered to a nursing woman.

Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R).

RISPERDAL(R) CONSTA(R)

If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor.

IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a decline in WBC and in the absence of other causative factors, discontinuation of Risperdal Consta should be considered.

Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

Priapism has been reported. Severe priapism may require surgical intervention.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported.

Administration: Care should be taken to avoid inadvertent injection into a blood vessel.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.

Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.

Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R).

Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.

The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increased (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial).

(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen and/or Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 28, 2008.

Source: Janssen Pharmaceuticals

View drug information on Risperdal Oral Formulation.

Posted in: Bipolar Disorder, Prescription Bipolar Drugs Comments (0)

FDA Issues Complete Response Letter For RISPERDAL(R) CONSTA(R) For The Adjunctive Maintenance Treatment Of Bipolar Disorder

Posted by admin on May 12th, 2009

12
May

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that the Food and Drug Administration (FDA) has asked for additional information regarding the company’s supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection. The sNDA, submitted in April 2008, sought approval for RISPERDAL(R) CONSTA(R) for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.

The Agency’s complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.

J&JPRD is currently evaluating the FDA’s complete response letter and will work with the Agency to resolve any outstanding questions.

Bipolar disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.(1)

RISPERDAL(R) CONSTA(R) is marketed in the U.S. by Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL(R) CONSTA(R) was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes’ proprietary Medisorb(R) drug-delivery technology, the RISPERDAL(R) CONSTA(R) formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies.

RISPERDAL(R) CONSTA(R) (risperidone) is used for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL(R) CONSTA(R)

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(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. J&JPRD does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

(1) Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun; 62(6):617-27.

Johnson & Johnson Pharmaceutical Research & Development
http://www.jnj.com

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Study Suggests New Treatment Approach May Be Needed For Management Of Depression In Some People With Bipolar Disorder

Posted by admin on May 11th, 2009

11
May

In a study published in The American Journal of Psychiatry, a team of researchers led by Mayo Clinic psychiatrist Mark Frye, M.D., attempted to identify what factors make some people with bipolar depression more likely to experience treatment-emergent mania (TEM).

Bipolar disorder, also known as manic-depressive illness, is a mental illness characterized by severe mood instability that can be serious and disabling. The deep mood swings from high (mania) to low (depression) may last for weeks or months, causing great disturbances in the lives of the person who has the illness, along with family and friends. Drugs known as mood stabilizers have proven effective at controlling the manic phase of the illness, but treating the depressive phase is more problematic. Antidepressants, although effective for some individuals, can trigger a rapid mood switch from depression to mania, a phenomenon called treatment-emergent mania.

“TEM is a serious and sometimes volatile adverse event, and we wanted to better understand who was at risk for developing this problem,” says Dr. Frye. People experiencing mania often exhibit poor judgment and impulsivity that can lead them to engage in highly unsafe or personally damaging behaviors, resulting in hospitalization, arrest and/or incarceration.

Dr. Frye’s team did a secondary analysis of data obtained in an earlier study led by Robert Post, M.D., and the Bipolar Collaborative Network. In that earlier study, researchers followed 176 study participants diagnosed with bipolar depression to measure the effectiveness of three different antidepressants. The secondary analysis led by Dr. Frye focused on 44 patients who experienced TEM after starting an antidepressant. Dr. Frye’s team compared this TEM group to 84 patients who responded favorably to an antidepressant and 44 patients who stopped taking the antidepressant due to lack of effectiveness or worsening depressive symptoms.

“We found that people who had minimal manic symptoms or a “mixed depression” presentation were at greatest risk for experiencing TEM,” says Dr. Frye.

Experts have begun to acknowledge that the common understanding of bipolar illness, once thought to be a disorder with two distinct phases (a manic upswing and a depressive downswing), may be incomplete. A recent study of over 1,300 patients conducted by Joseph Goldberg, M.D., Mount Sinai School of Medicine, reported that two-thirds of the depressed bipolar patients had minimal or mild manic symptoms “mixed” together.

“We’re learning that this illness does not occur in two neat, clear-cut phases, but rather a mix of the two,” says Dr. Frye. “Our data would suggest that people with mixed depression may need to stay away from antidepressants and work with their health care providers to find alternative treatments, such as mood stabilizers, to help manage the depressive phase of their illness.” Further research is encouraged to better understand the best treatment for these mixed presentations.

Other authors for this article include: Gerhard Helleman, Ph.D., David Geffen School of Medicine at UCLA, Los Angeles; Susan McElroy, M.D., University of Cincinnati College of Medicine; Lori Altshuler, M.D., David Geffen School of Medicine at UCLA, Los Angeles; David Black, Ph.D., Pediatric and Developmental Neuropsychiatry, National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Bethesda, Md., and David Geffen School of Medicine at UCLA, Los Angeles; Paul Keck Jr., M.D., University of Cincinnati College of Medicine; Willem Nolen, M.D., Ph.D., University Medical Center Groningen, University of Groningen, the Netherlands; Ralph Kupka, M.D., Ph.D., Altrecht Institute for Mental Health Care and University Medical Centre, Utrecht, the Netherlands; Gabriele Leverich, Biological Psychiatry Branch, NIMH, NIH, Bethesda, Md.; Heinz Grune, M.D., Institute of Neuroscience, Newcastle University, Newcastle, England; Jim Mintz, Ph.D., University of Texas San Antonio; Robert Post, M.D., George Washington School of Medicine, Penn State College School of Medicine and Bipolar Collaborative Network, Bethesda, Md.; and Trisha Suppes, M.D., Ph.D., Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.

To obtain the latest news releases from Mayo Clinic, go to http:// www.mayoclinic.org/news. MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories.

Mayo Clinic
http://www.mayoclinic.com

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Optimism For Bipolar Disorder And Schizophrenia If Psychiatrists Abandon 19th Century Dogma, UK

Posted by admin on May 11th, 2009

11
May

Nineteenth century thinking about schizophrenia and bipolar disorder must be abandoned if psychiatry is to progress, said a leading UK psychiatrist. At a meeting of the Biochemical Society, Professor Nick Craddock from Cardiff University urged his profession to embrace the opportunities offered by new research methodologies.

Advanced technology and the large sample sizes in research have led to unprecedented advances in the identification of specific genetic risk factors for psychiatric disorders as recently as the last two years. “For more than 100 years there has been a widespread assumption that bipolar disorder (manic depression) and schizophrenia are completely separate diseases. Recent evidence, particularly from molecular genetics, shows the situation is not so simple. Some of the susceptibility genes are shared,” he said.

Strong genetic associations have been reported in bipolar disorder and schizophrenia. Emerging data provide a powerful resource for exploring the relationship between psychiatric characteristics. “This new knowledge will help to explain why some people receive a diagnosis of schizophrenia at one time and bipolar disorder at another time and why some receive a mixed diagnosis - so called ’schizoaffective’ disorder,” he said.

It is already clear that, in general, genetic associations are not specific to one of the traditional diagnostic categories. For example, one gene variation (ZNF804A) is associated with risk of both bipolar disorder and schizophrenia, and some rare ‘copy number’ variations are associated with the risk of autism and epilepsy as well as schizophrenia. “There is an urgent need to think beyond diagnostic “boxes” and consider how variations in brain biology and function lead to the huge range of clinical variations seen in people with psychiatric diseases,” said Professor Craddock.

Whilst many family and twin studies have demonstrated the importance of genetic factors influencing susceptibility to bipolar disorder, only recently have research technologies started to identify these risk factors. It is, according to Professor Craddock, a successful start to a long journey.

“We know that there are many genes involved in bipolar disorder. Two such genes have been strongly implicated in recent studies of over 10,000 individuals,” he said. The action of both genes is thought to be through effects on the basic control of the excitability of nerve cells. Although not of immediate clinical use, this new understanding will open up new avenues for research and should ultimately lead to improved treatments.

Professor Craddock concluded, “This is a time of rapid progress in bipolar disorder research. Those with illness can be optimistic for the next generation.”

Source
Biochemical Society

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Lack Of Grey Matter In Brain Is Linked To Schizophrenia And Bipolar Disorder

Posted by admin on May 10th, 2009

10
May

A research study led by scientists from the Gregorio MaraÃ±Ã³n University Hospital in Madrid and the Network of Centres for Biomedical Research in Mental Health Networks (CIBERSAM) shows that adolescents experiencing a first outbreak of psychosis have lower levels of grey matter in their brains than healthy teenagers. Strangely, this change was seen in patients suffering from various psychoses, including bipolar disorder and schizophrenia.

The aim of the study was to examine and locate differences in the volume of grey matter in the brains of healthy people (controls) and individuals diagnosed with psychotic outbreaks in infancy or adolescence. The researchers broke such psychosis down into three sub-groups schizophrenia, bipolar disorder and other psychoses that did not fit into either of the other two classifications.

The study, published recently in the Journal of the American Academy of Child and Adolescent Psychiatry, analysed a sample of 121 people aged between 7 and 18, inclusive. All the patients and controls were examined using magnetic resonance imaging in order to detect any possible changes in the structure of their brains.

“The interesting thing was that we found common alterations among those with two types of clinically-differentiated psychoses, schizophrenia and bipolar disorder, and this could help to improve diagnosis of these illnesses,” Santiago Reig, one of the study’s authors and a researcher in the Medical Imaging Laboratory of the Gregorio MaraÃ±Ã³n Hospital, tells SINC.

The study confirmed these lower levels of grey matter, the brain substance in which neurone cells are concentrated. This lack, which was shared between the schizophrenia and type 1 bipolar diaorder sufferers, means the functions of this part of the brain are “somehow atrophied”.

In addition, the technique used by the experts can pinpoint the location of these alterations. For example, “patients with early psychotic outbreaks (before the age of 18) showed alterations in the medial prefrontal gyrus region of the brain, which controls processes such as cognition and the regulation of sensations”, says Reig.

Improving diagnosis

“Anything that helps to detect alterations shared between distinct pathologies can help in the development of drugs and in finding common characteristics between these different diseases,” the researcher tells SINC. “Results like these are fundamental for the diagnosis and treatment of illnesses,” he adds.

However, it is important not to draw any causal link between alterations in this area of the brain and the appearance of these pathologies. Psychiatric disorders need more complex diagnosis. What the research does show, however, is that the majority of people with schizophrenia and type 1 bipolar disorder do suffer from this lack of grey matter and the majority of healthy people have normal levels of this substance.

“We still do not know whether this loss of grey matter is caused by the disorder or not,” says Reig. This is just one more piece of the puzzle to help in understanding common features of psychiatric disorders. “Maybe relating these developments with other new findings will one day help us to solve the riddle of psychiatric disorders,” he concludes.

Plataforma SINC
http://www.plataformasinc.es

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Common Causes Of Schizophrenia And Bipolar Disorder

Posted by admin on May 10th, 2009

10
May

Schizophrenia and bipolar disorder have the same genetic causes, according to a study from Karolinska Institutet published today in the highly respected journal The Lancet. The results throw the current separate classification of the diseases into question.

Schizophrenia and bipolar disorder (also known as manic-depressive illness) are the two most common psychotic disorders. For over a century, the two diseases have been treated as distinct by clinical practitioners and researchers as regards definitions and risk factors. However, such strict classification has met increasing scepticism over the years, partly owing to the results of modern genetic science, which has shown that certain genes seem to affect both disorders.

To study whether schizophrenia and bipolar disorder have the same genetic causes, Swedish scientists analysed the records of two million families, including 35,985 patients with schizophrenia, 40,487 patients with bipolar disorder, and the blood relatives of both.

Their results show that members of families in which someone has either schizophrenia or bipolar disorder run an increased risk of developing the same condition. The results also show that this is chiefly the result of genetic factors, and only slightly due to shared environmental factors. The scientists also found that patients with schizophrenia are also more prone to bipolar disorder, and that relatives of patients with one of the diseases are more likely to have relatives with the other.

According to the researchers, the results, taken as a whole, provide convincing proof that schizophrenia and bipolar disorder are very much hereditary diseases, and that they share, in part, a common genetic cause. They also argue that it is important for clinicians and researchers to take this common genetic background into account when studying and treating schizophrenia and bipolar disorder.

The study was funded by the Swedish Council for Working Life and Social Research and the Swedish Research Council.

Publication:
“Common genetic determinants of schizophrenia and bipolar disorder in Swedish families: a population-based study”
Paul Lichtenstein, Benjamin H Yip, Camilla Bjork, Yudi Pawitan, Tyrone D Cannon, Patrick F Sullivan, Christina M Hultman
The Lancet, 16 January 2009

Download images: http://ki.se/pressimages

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.

Karolinska Institutet

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