Bipolar disorder appears to increase the risk of early death from medical illnesses, according to a literature review study published as the lead article this week in the journal Psychiatric Services.

The researchers comprehensively reviewed 17 studies involving more than 331,000 patients. Evidence suggested that people with bipolar disorder have a higher mortality from natural causes compared to people in the general population of similar age and gender but without mental illness. The various studies indicated that the risk was from 35 percent to 200 percent higher. The risk is the same for men and women. The most common conditions leading to premature death were heart disease, respiratory diseases, stroke, and endocrine problems such as diabetes.

“The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person’s risk of early death,” said Dr. Wayne Katon, a University of Washington (UW) professor of psychiatry. He co-authored the study with third-year UW psychiatry resident Babak Roshanaei-Moghaddam. The article is titled, “Premature Mortality from General Medical Illnesses Among Persons with Bipolar Disorder: A Review.” Katon is a noted researcher on the interplay between life-shortening medical conditions and mood disorders.

People with bipolar disorder tend to have manic phases and depressed phases in their lives. During mania, they might be too wound up to sleep, their thoughts might race, and they might have boundless energy. During depression, they might feel painfully sad, hopeless, and immobilized.

In the past, the higher premature death rate among people with bipolar disorder was attributed to a higher rate of suicide and accidents. More recently, Katon said, researchers are finding that, while rates of suicides and accidents are indeed greater among those with bipolar disorder compared to the general population, they only partly account for the higher premature death rate. Emerging evidence, Katon said, shows that the majority of early deaths among people with bipolar disorder come from medical conditions.

As psychiatric conditions such as bipolar disorder become more treatable, Katon said, “We’re saving people from this illness and losing them to other medical illnesses.”

The possible reasons for this higher risk of premature death are manifold. Many factors could be contributing to poor physical health among people with bipolar disorder, according to the published report. These include unhealthy diet, binge eating, lack of exercise, smoking, substance abuse, social deprivation, living alone, homelessness, lack of access to health services, biased attitudes of health professionals towards people with psychiatric illnesses, failure among psychiatrists to address their patient’s medical problems, or delaying medical care because of the overriding need for psychiatric treatment.

Biological abnormalities associated with bipolar illness might also be shortening lives, Katon noted. The illness can stress the immune system and the hypothalamic-pituitary axis, a system that controls many body processes. Bipolar disorders also heighten the activity of the sympathetic nervous system, which sets off the fight-or-flight response to stress.

Katon also noted that some new antipsychotic medications used to successfully treat bipolar disorders are safer and more comfortable for the patient in some ways than previous medications, but can cause weight gain leading to obesity and other metabolic changes that predispose people to Type 2 diabetes. Some mood stabilizers, Katon added, also are associated with weight gain and metabolic disorders.

Katon mentioned new attempts to try to reduce premature death in people with bipolar disorder. These include providing psychiatrists and other mental health professionals with guidelines and training in monitoring their patients’ basic physical health and teaching them how to advise their patients about smoking cessation, exercise and other preventive measures.

“Changes are also occurring in medical schools to teach new physicians in all specialties how to recognize psychiatric illnesses and to understand the serious health risks associated with mental illness,” Katon said.

Increasingly, community mental health centers are adding primary-care physicians and nurse practitioners to the staff to see patients for medical conditions, he said. Medical specialty centers are also adding mental health professionals to diagnose and treat the depression, anxiety and other psychic distress that often accompany serious illnesses.

“Psychiatrists are now on the staff of a growing number of medical specialty clinics, such as centers for diabetes, heart disease and cancer, and at primary-care centers, such as family medicine practices,” Katon said. “Mental health professionals are working side-by-side with providers who treat medical illnesses. New approaches to health care and wellness programs are being tested at a number of places to find effective models for preventing premature deaths associated with bipolar disorder and other mental illnesses.”

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Article adapted by Medical News Today from original press release.
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Source: Leila Gray

University of Washington

• Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODTTM), Co-Developed With GlaxoSmithKline

Continuing their groundbreaking research into the treatment of mood disorders in older adults, psychiatrists at the Weill Cornell Institute of Geriatric Psychiatry at the NewYork-Presbyterian Hospital/Westchester Division in White Plains will begin new studies on the effects of quetiapine (Seroquel: Astra Zeneca) and lamotrigine (Lamictal: GlaxoSmithKline). Although both drugs have been approved for aspects of the treatment of patients with bipolar disorder, to date there has been limited research into their effects on older adults with bipolar depression.

The studies are being led by Dr. Robert C. Young, professor of psychiatry at Weill Cornell Medical College, and his colleagues at the Institute of Geriatric Psychiatry. With more than 30 years of clinical and research experience, Dr. Young’s focus has been to develop information that can improve the treatment of older adults suffering severe mood disorders.

Dr. Young, an attending psychiatrist at NewYork-Presbyterian/Westchester, said: “To date, most bipolar disorder treatment studies have been conducted in younger patients. In some older bipolar patients a good symptom response is difficult to achieve, and they often have recurring symptoms, disability, multiple medical disorders and increased mortality rates. We hope that findings from these studies will help physicians better manage the care of their geriatric bipolar patients.”

Eligible participants must be 60 years of age or older with a diagnosis of bipolar disorder and currently suffering from symptoms of depression. They will be required to meet with a psychiatrist one day per week for a few hours and receive medication management from the treatment team.

Dr. Young and his colleagues are also continuing to lead another study, funded by the National Institute of Mental Health (NIMH) and now in its fourth year, comparing the efficacy of two commonly used mood stabilizers, lithium and valproate, for the treatment of bipolar disorder in older adults. To date, more than 140 individuals in six study sites across the United States including NewYork-Presbyterian/Westchester have participated.

Dr. Young added: “We’ve heard from some participants in the NIMH study that they have gotten satisfaction in knowing that the findings from this important research may be of benefit to other older individuals — now and in the years ahead — who are similarly afflicted with bipolar disorder.”

Bipolar disorder involves periods of elevated mood — mania or hypomania — and periods of depression, or “mixed” episodes in which patients have both kinds of symptoms. Examples of manic symptoms are high levels of energy, going without sleep for extended periods, elated mood or irritability, and impulsive or reckless behavior. Patients may not recognize that they are having symptoms.

The studies are funded by Astra Zeneca and GlaxoSmithKline. Dr. Young has received an honorarium for a talk sponsored by Astra Zeneca.

NewYork-Presbyterian Hospital/Westchester Division

NewYork-Presbyterian Hospital/Westchester Division, opened in 1894, is one of the world’s most advanced centers for psychiatric care. The Westchester Division serves children, adolescents, adults and the elderly with comprehensive outpatient, day treatment, partial hospitalization and inpatient services. In addition to clinical treatment, the Westchester Division is also a center for interdisciplinary medical research and education through its academic affiliate, Weill Cornell Medical College. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children’s Hospital and NewYork-Presbyterian Hospital/The Allen Pavilion. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report.

Source: NewYork-Presbyterian Hospital

• FDA Approves Lilly's Zyprexa For Two Adolescent Indications
• Eighth International Conference On Bipolar Disorder To Be Held In Pittsburgh, June 25 To 27
• FDA Issues Complete Response Letter For RISPERDAL(R) CONSTA(R) For The Adjunctive Maintenance Treatment Of Bipolar Disorder

Alkermes, Inc. (NASDAQ: ALKS) announced that the Food and Drug Administration (FDA) has asked Alkermes’ partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), for additional information regarding the supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection). The sNDA, submitted in April 2008, sought approval for RISPERDAL CONSTA 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 CONSTA is marketed in the U.S. by Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL CONSTA 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® drug-delivery technology, the RISPERDAL CONSTA 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.

RISPERDAL CONSTA is used for the treatment of schizophrenia.

Important Safety Information For Risperdal® Consta®

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection) 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® CONSTA® 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® CONSTA® 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® CONSTA® 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® CONSTA®. 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® CONSTA® 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. The connection between prolactin levels and side effects is unknown.

Some people taking RISPERDAL® CONSTA® 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.

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

RISPERDAL® CONSTA® 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.

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® CONSTA®. Caution should be exercised when RISPERDAL® CONSTA® is administered to a nursing woman.

RISPERDAL® CONSTA® 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® CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL® CONSTA®.

In a study of people taking RISPERDAL® CONSTA®, 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.

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

About Alkermes

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients’ lives. Alkermes developed, manufactures and commercializes VIVITROL® for alcohol dependence and manufactures RISPERDAL® CONSTA® for schizophrenia. Alkermes’ robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company’s business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others, the ability of Alkermes’ partner to respond to the FDA complete response and the ultimate decisions by the FDA relating to the sNDA for RISPERDAL CONSTA for adjunctive maintenance treatment in patients with bipolar disorder. For further information with respect to factors that could cause the company’s actual results to differ materially from expectations, reference is made to the reports the Company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

Medisorb is a registered trademark of Alkermes, Inc., VIVITROL is a registered trademark of Cephalon, Inc. and RISPERDAL CONSTA is a registered trademark of Janssen-Cilag.

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.

Source:
Alkermes, Inc.

Schering-Plough Corporation (NYSE: SGP) announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets, which was received in January 2009. SAPHRIS is under review for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

The action letter included proposed labeling for both indications and a request for supplemental data from the existing asenapine database. No additional clinical trials were requested.

“We are pleased to have submitted the SAPHRIS complete response within a month from receipt of the FDA action letter. We look forward to working with the agency to finalize labeling and gain approval, and to bringing a new therapy to patients with schizophrenia and bipolar I disorder,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute.

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the antipsychotic agent. The New Drug Application (NDA) for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the clinical development of, the commercial plans for and the potential market for SAPHRIS. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including uncertainties in the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A. “Risk Factors” in the third quarter 2008 10-Q, filed Oct. 29, 2008.

Schering Plough Corporation
http://www.schering-plough.com

• ">
• Eighth International Conference On Bipolar Disorder To Be Held In Pittsburgh, June 25 To 27

Children and teens of parents with bipolar disorder appear to have an increased risk of early-onset bipolar disorder, mood disorders and anxiety disorders, according to a report in the March issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

As many as 60 percent of patients with bipolar disorder experience symptoms before age 21, according to background information in the article. Identifying the condition early may improve long-term outcomes, potentially preventing high psychosocial and medical costs. Having family members with bipolar disorder is the best predictor of whether an individual will go on to develop the condition, the authors note. “Therefore, carefully evaluating and prospectively following the psychopathology of offspring of parents with bipolar disorder and comparing them with offspring of parents with and without non-bipolar disorder psychopathology, are critical for identifying the early clinical presentation of bipolar disorder,” they write.

Boris Birmaher, M.D., of Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, and colleagues compared 388 offspring (ages 6 to 18) of 233 parents with bipolar disorder to 251 offspring of 143 demographically matched control parents. Parents were assessed for psychiatric disorders, family psychiatric history, family environment and other variables, and were also interviewed about their children. Children were assessed directly for bipolar disorder and other psychiatric disorders by researchers who did not know their parents’ diagnoses.

Compared with the offspring of control parents, children of parents with bipolar disorder had an increased risk of having a bipolar spectrum disorder (41 or 10.6 percent vs. two or 0.8 percent) and having any mood or anxiety disorder. Children in families where both parents had bipolar disorders also were more likely than those in families containing one parent with bipolar disorder to develop the condition (four of 14 or 28.6 percent vs. 37 of 374 or 9.9 percent); however, their risk for other psychiatric disorders was the same as offspring of one parent with bipolar disorder.

“Consistent with the literature, most parents with bipolar disorder recollected that their illness started before age 20 years and about 20 percent had illness that started before age 13 years,” the authors write. “In contrast, most of their children developed their first bipolar disorder episode before age 12 years, suggesting the possibility that parents were more perceptive of their children’s symptoms early in life or perhaps that bipolar disorder has more penetrance and manifests earlier in new generations.”

The findings have important clinical implications, they note. “Clinicians who treat adults with bipolar disorder should question those who are parents about their children’s psychopathology to offer prompt identification and early interventions for any psychiatric problems that may be affecting the children’s functioning, particularly early-onset bipolar disorder,” they continue. Further studies are needed to help determine the clinical, biological and genetic risk factors that may be modified to prevent the development of psychiatric disorders in the offspring of those with bipolar disorder.

Arch Gen Psychiatry. 2009;66[3]:287-296.
http://archpsyc.ama-assn.org/cgi/content/short/66/3/287

Arch Gen Psychiatry

• Schering-Plough Submits Response To FDA For SAPHRIS(TM) (asenapine) In The Acute Treatment Of Both Schizophrenia And Bipolar I Disorder
• 1A binding reductions in euthymic bipolar disorder patients]]>
• Faulty Body Clock May Make Kids Bipolar
• Impax Receives Final FDA Approval For Generic Depakote(R) Extended-Release 250mg Tablets
• RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed The Time To Relapse In Patients With Bipolar I Disorder
• New Research Under Way To Study Treatment For Older Adults With Bipolar Disorder
• Combined Data From Four Large-Scale Studies Demonstrate The Efficacy And Tolerability Of Seroquel In Bipolar Depression
• If Bipolar Disorder Is Over-Diagnosed, What Are The Actual Diagnoses?

Scientists have discovered how the toxoplasmosis parasite may trigger the development of schizophrenia and other bipolar disorders.

The team from the University of Leeds’ Faculty of Biological Sciences has shown that the parasite may play a role in the development of these disorders by affecting the production of dopamine - the chemical that relays messages in the brain controlling aspects of movement, cognition and behaviour.

Toxoplasmosis, which is transmitted via cat faeces (found on unwashed vegetables) and raw or undercooked infected meat, is relatively common, with 10-20% of the UK population and 22% of the US population estimated to carry the parasite as cysts. Most people with the parasite are healthy, but for those who are immune-suppressed - and particularly for pregnant women - there are significant health risks that can occasionally be fatal.

Dr Glenn McConkey, lead researcher on the project, says: “Toxoplasmosis changes some of the chemical messages in the brain, and these changes can have an enormous effect on behaviour. Studies have shown there is a direct statistical link between incidences of schizophrenia and toxoplasmosis infection and our study is the first step in discovering why there is this link.”

The parasite infects the brain by forming a cyst within its cells and produces an enzyme called tyrosine hydroxylase, which is needed to make dopamine. Dopamine’s role in mood, sociability, attention, motivation and sleep patterns are well documented and schizophrenia has long been associated with dopamine, which is the target of all schizophrenia drugs on the market.

The team has recently received $250,000 (£160,000) to progress its research from the US-based Stanley Medical Research Institute, which focuses on mental health conditions and has a particular emphasis on bipolar illnesses.

Dr McConkey says: “It’s highly unlikely that we will find one definitive trigger for schizophrenia as there are many factors involved, but our studies will provide a clue to how toxoplasmosis infection - which is more common than you might think can impact on the development of the condition in some individuals.

“In addition, the ability of the parasite to make dopamine implies a potential link with other neurological conditions such as Parkinson’s Disease, Tourette’s syndrome and attention deficit disorders, says Dr McConkey. “We’d like to extend our research to look at this possibility more closely.”

campuspr
http://www.campuspr.co.uk

• Buy Seroquel Online
• GPR50 gene linked to affective disorder]]>
• FDA Approves Saphris Tablets (asenapine) To Treat Schizophrenia And Bipolar Disorder

Cephalon, Inc. (Nasdaq: CEPH) announced positive results from a phase two clinical trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder. An estimated two million American adults are affected by bipolar I disorder, which is characterized by fluctuations between extreme highs (manic) and lows (depressed) in mood. People with bipolar disorders cycle between periods of manic or depressive mood and typically spend more time in the depressed phase of the illness.

The eight-week, double-blind, placebo-controlled study evaluated the efficacy and safety of NUVIGIL (150 mg/day) as an adjunctive therapy to mood stabilizers in 257 patients with bipolar I disorder, who experienced a major depressive episode that was not completely managed by their other treatments. Patients in the study taking NUVIGIL as adjunctive therapy showed improvement of depressive symptoms (p=0.042) as measured on the primary endpoint - the 30-Item Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30) scale. The IDS-C30 scale is an instrument used to evaluate depressive episodes and associated symptoms. The results of this study will be presented at an upcoming medical meeting.

“We are encouraged that the results of this study point toward the potential utility of NUVIGIL in managing the depressive episodes in bipolar I disorder,” said Dr. Lesley Russell, Executive Vice President and Chief Medical Officer at Cephalon. “We now plan to conduct phase three trials to further evaluate the efficacy and safety of NUVIGIL in this patient population.”

NUVIGIL was generally well-tolerated in the study. The incidence of mania, hypomania, depression and suicidal ideation were comparable between the NUVIGIL and placebo groups. There were two serious adverse events of mania in the placebo group but none in the NUVIGIL group. Other adverse events that occurred more frequently in the NUVIGIL versus the placebo group included restlessness and anxiety.

Cephalon is preparing to launch NUVIGIL, the longer-lasting isomer of modafinil, in the third quarter of 2009. NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not approved for the treatment of bipolar disorders, depression or their associated symptoms.

The U.S. Food and Drug Administration-approved prescribing information for NUVIGIL, including a bolded warning, is available at http://www.NUVIGIL.com.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.

The company’s proprietary products in the United States include: AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), TREANDA(R) (bendamustine hydrochloride) for Injection, FENTORA(R) (fentanyl buccal tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II).

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Cephalon, Inc.
http://www.cephalon.com

• Patients With Bipolar Disorder At Increased Risk For Wide Range Of Health Problems, Thomson Reuters Study Finds
• Faulty Body Clock May Make Kids Bipolar

Researchers at MIT’s Picower Institute for Learning and Memory have found that inhibiting a key brain enzyme in mice reversed schizophrenia-like symptoms. The finding, reported in the March 20 issue of Cell, identified how a particular gene controls this brain enzyme. Better understanding of the relationship could lead to new drug treatments for schizophrenia, the severe brain disorder that affects about 1 percent of the population and is characterized by hallucinations, delusions, poor social and emotional functioning and disorganized thoughts.

The Picower research focused on a gene known as DISC1 (short for “disrupted in schizophrenia 1″), which was first identified in the 1990s by researchers studying the genetic makeup of a large Scottish family with mental and behavioral disorders. DISC1 has since been shown to help brain neuronal cells migrate to their correct positions and to help new neurons grow in the developing brain, but its role was not well understood.

Now, Li-Huei Tsai, the Picower Professor of Neuroscience in MIT’s Department of Brain and Cognitive Sciences, and colleagues have shown for the first time that DISC1 directly inhibits the activity of a brain enzyme called glycogen synthase kinase 3 beta, also known as GSK3B.

Lithium chloride, the mood-stabilizing drug often prescribed for schizophrenia and bipolar disorder, also acts on GSK3B.

“This work for the first time provides a detailed explanation of how DISC1 functions normally in our brains,” said Tsai, a Howard Hughes Medical Institute investigator and director of the neurobiology program of the Stanley Center for Psychiatric Research at the Broad Institute of Harvard and MIT.

“With this new knowledge of the DISC1-GSK3B interaction, one of the goals is to develop new drugs targeting schizophrenia, providing some hope that this devastating disease will be treated more effectively in the near future,” she said.

Growing new neurons

Working with mice, Tsai and colleagues found that DISC1 regulates the growth of neural stem cells in both developing and adult brains. “During brain development, a fine-tuned mechanism regulates when neural stem cells divide and replenish their own population and when they turn into newborn neurons that will mature and grow appropriate connections with other neurons,” Tsai said.

Tsai and colleagues found that halting expression of the DISC1 gene in neural stem cells causes them to stop dividing and prematurely turn into newborn neurons.

Eliminating DISC1 in adult mouse neural stem cells caused similar defects and produced behavioral changes such as hyperactivity, a symptom of schizophrenia in mice models of the disease. “Giving a chemical inhibitor of GSK3B to these mice completely reversed their abnormal behavior,” Tsai said.

DISC1 works by directly inhibiting the activity of GSK3B, a target of the drug lithium. “It seems that DISC1 regulates the balance between neural stem cell self-renewal and turning into neurons, which impacts overall brain circuitry and can lead to compromised cognition and behavioral abnormalities,” Tsai said. “Understanding the normal function of DISC1 in the brain could lead to new information on how schizophrenia arises due to genetic predisposition and environmental factors.”

In addition to Tsai, co-authors are Picower Institute postdoctoral fellow Yingwei Mao; MIT Brain and Cognitive Sciences graduate student Xuecai Ge, Picower Institute postdoctoral associate Christopher L. Frank; Broad Institute researchers Jon M. Madison, Erin M. Berry, Takahiro Soda and Karun K. Singh; and colleagues at Massachusetts General Hospital, the Harvard-MIT Division of Health Sciences and Technology and the University of Washington School of Medicine.

This work was supported by the National Institutes of Health, the Stanley Center, the National Alliance for Research on Schizophrenia and Depression (NARSAD) and the Human Frontier Science Program.

Written by Deborah Halber, Picower Institute

Source
MIT

Impax Laboratories, Inc. (NASDAQ: IPXL) confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 250mg Extended-release Tablets. The Company also received tentative approval on the 500mg tablets and expects to receive final approval on August 3, 2009, upon expiration of the 180-day exclusivity period. Abbott Laboratories markets Depakote® ER for the treatment of epilepsy and bipolar disorders.

The Company expects to launch both the 250mg and 500mg tablets on August 3, 2009, through Global Pharmaceuticals, Impax’s generic division.

According to Wolters Kluwer Health, U.S. sales of Depakote® ER 250mg and 500mg tablets were approximately $115 million and $796 million, respectively, for the 12 months ended March 2009.

Source
Impax Laboratories, Inc.

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A national audience of psychiatrists and psychiatric advanced practitioners is gathering in Chicago April 2-4, 2009 for the continuing medical education (CME) conference “Bipolar Disorder and ADHD: Solving Clinical Challenges, Improving Patient Care” at the Westin Chicago River North.

More than 300 clinicians have registered for the conference, which is being produced by CURRENT PSYCHIATRY publisher Dowden Health Media and the American Academy of Clinical Psychiatrists (AACP). Psychiatrists and advanced practitioners can still register to attend at the meeting’s Web site (www.CurrentPsychiatry.com/AACP). The meeting has been approved for up to 18.5 AMA PRA Category 1 CME credits.

“CURRENT PSYCHIATRY’S expertise in creating peer-reviewed content and managing events dovetails perfectly with the AACP’s mission to provide information-sharing forums for psychiatric practitioners and academicians,” said AACP President Sanjay Gupta, MD. “Together, we have assembled a compelling program.”

The faculty of psychiatric educators and clinicians includes meeting chair Richard Balon, MD, Wayne State University; Kiki Chang, MD, Stanford University; Marlene Freeman, MD, Massachusetts General Hospital; S. Nassir Ghaemi, MD, MPH, Tufts Medical Center; Joseph Goldberg, MD, Mount Sinai School of Medicine; and Frederick Goodwin, MD, George Washington University.

Topics to be discussed at this learning-focused meeting include:

– ADHD in children, adolescents, and adults managing bipolar disorder during pregnancy and the postpartum use of stimulants, antidepressants, antipsychotics, and mood stabilizers in patients with bipolar disorder alcohol abuse in patients with bipolar disorder and ADHD.

*Exhibiting companies include: AstraZeneca, Neuronetics, Prescribing for Better Outcomes (University of North Carolina), Shire Pharmaceuticals and Teva Pharmaceuticals.

Dowden Health Media, a division of Lebhar-Friedman, Inc., publishes CURRENT PSYCHIATRY and other peer-reviewed print and online journals such as OBG MANAGEMENT, THE JOURNAL OF FAMILY PRACTICE, and MAYO CLINIC PROCEEDINGS. Dowden also produces CME conferences such as the Minimally Invasive Surgery Symposium (MISS), promotional education programs for physicians, and health-related consumer newsletters and Web sites.

The American Academy of Clinical Psychiatrists (http://www.AACP.com) brings together clinical practitioners and academicians to enhance care of patients with psychiatric illness by emphasizing practical knowledge. Members keep abreast of scientific developments in the diagnosis, etiology, and treatment of psychiatric disorders through annual conferences, online communications, and the indexed journal, the Annals of Clinical Psychiatry.

Dowden Health Media
http://www.dowdenhealth.com

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