ABILIFY® (aripiprazole), when used in combination with lithium or valproate, is a generally well-tolerated long-term treatment for patients with Bipolar I Disorder, who are partially non-responsive to lithium or valproate monotherapy.1 The data presented today at the annual congress for the World Psychiatric Association (WPA) report a favourable long-term safety profile for ABILIFY in combination with lithium or valproate.1

Professor Eduard Vieta, lead study investigator and Professor of Psychiatry and Director of the Bipolar Disorders Programme of the Hospital Clinic at the University of Barcelona, Spain, said “As a doctor, I value data on safety, tolerability and efficacy as extremely important. Clinicians look for treatments that are efficacious and tolerable in the long term. This study reports that aripiprazole can provide Bipolar I Disorder patients with a combination treatment option with the benefits of good long-term safety and tolerability.”

The efficacy and safety of ABILIFY, used in combination with lithium or valproate for the treatment of patients with Bipolar I Disorder, were investigated during a 6-week multicentre, double-blind, randomized, placebo-controlled study involving 348 patients, followed by a 46-week open-label extension phase.

In total, 283 patients entered the extension phase of the study, (prior placebo n=104 vs prior ABILIFY n=179).

The primary objective of the extension phase was to assess the long-term safety and tolerability of ABILIFY in combination with lithium or valproate. Patients in the study were followed up for an additional 46 weeks.

The open-label extension data, presented at the WPA congress, showed that ABILIFY, in combination with lithium or valproate, continued to be well-tolerated with no new or unexpected adverse side effects.

Evaluation of long-term efficacy was a secondary objective due to the open-label nature of the extension phase. Since there was no double-blind control, definitive statements regarding efficacy can not be made, but results support that improvements in bipolar symptoms were maintained through 52 weeks.1

The Young Mania Rating Scale (YMRS) Total Score and the Clinical Global Impressions-Bipolar-Severity of illness (CGI-BP-S) (Mania) Score continued to improve from the end of the double-blind phase to week 52.1 Specifically, the YMRS Total Score (Last Observation Carried Forward [LOCF]) continued to improve in both groups (-3.31 and -2.94 in patients receiving lithium and valproate, respectively.) CGI-BP-S (Mania) Score (LOCF) also improved in both groups (-0.39 and -0.57 in patients receiving lithium and valproate, respectively.) 1

The results support previous clinical trials for ABILIFY, which demonstrated efficacy and safety and overall improved quality of life in patients with Bipolar I Disorder, when used as monotherapy. 2, 3

Bipolar I Disorder is characterised by the occurrence of one or more Manic Episodes or Mixed Episodes. A Manic Episode is defined by a distinct period during which there is an abnormally and persistently elevated, expansive, or irritable mood.
The mood disturbance must last for at least 1 week (unless hospitalisation is required).

A Mixed Episode is characterised by a period of time (lasting at least 1 week) in which the criteria are met both for a Manic Episode and a Major Depressive Episode.4 Untreated Manic Episodes generally last three to six months and Depressive Episodes generally last six to 12 months without treatment.5

Bipolar Disorder affects 2.4 million people in Europe.6

About Bristol-Myers Squibb and Otsuka Pharmaceutical Co. Ltd

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the development and commercialisation of ABILIFY®. ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: “Otsuka - people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 106 companies and employs approximately 33,000 people in 18 countries and regions worldwide.

Bristol-Myers Squibb is a global biopharmaceutical whose mission is to extend and enhance human life.

About ABILIFY® (aripiprazole) in schizophrenia

ABILIFY® (aripiprazole) is manufactured in 5 mg, 10 mg, 15 mg and 30 mg tablets, 10 mg and 15 mg orodispersible tablets and 1 mg / ml oral solution.

ABILIFY is currently indicated for the treatment of schizophrenia; the current recommended dosing for ABILIFY in schizophrenia is a once-daily dose. The recommended starting dose is 10mg or 15mg, with a maintenance dose of 15mg.

About ABILIFY® (aripiprazole) in Bipolar I Disorder

Manic Episodes:

The recommended starting dose for ABILIFY is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see SmPC section 5.1). Some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.

Recurrence prevention of Manic Episodes in Bipolar I Disorder:

For preventing recurrence of Manic Episodes in patients who have been receiving ABILIFY, continue therapy at the same dose. Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.

The Marketing Authorisation Application for ABILIFY in Europe is supported by 8 Phase III clinical studies.

References

- Vieta E. et al. A 46 week evaluation of aripiprazole in combination with lithium/valproate in bipolar mania. Poster # 131. Presented at the annual congress of the World Psychiatric Association, 2 April 2009.

- Keck P.E, Sanchez R, Torbeyns A et al. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, placebo- and lithium-controlled study (CN138-135). Poster presented at APA 160th Annual Meeting, San Diego, U.S., 19-27 May 2007.

- Dillenschneider A, Sanchez R, McQuade R.D, Torbeyns A. Aripiprazole monotherapy in acute bipolar I mania: a randomized, placebo- and haloperidol-controlled study (CN138-162). Poster presented at WEBP, Strasbourg, France, 13-15 December, 2007.

- American Psychiatric Association 2000. (DSM-IV-TR) Diagnostic and statistical manual of mental disorders, 4th edition, text revision. Washington, DC: American Psychiatric Press, Inc. p320-323, 328-330, 333, 350-351.

- Royal College of Psychiatrists. Bipolar Disorder (Manic Depression). Date accessed 11 January 2007.

- Wittchen H-U, Jacobi F. Size and burden of mental disorders in Europe - a critical review and appraisal of 27 studies. Eur Neuropsychopharmacol 2005; 15:357-376.

Source
Bristol-Myers Squibb

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A new national online survey of more than 2,000 people living with bipolar disorder and 500 physicians who treat patients with bipolar disorder identified that the greatest concern among people living with bipolar disorder (73%) is that their symptoms will impact daily life, such as family, relationships, or job.(1) In particular, about 9 in 10 patients (89%) said they have cancelled social engagements because of bipolar depression.(1) In addition, people with bipolar disorder reported that bipolar depressive symptoms affected their ability to manage housework (73%) and run errands (59%).(1) This online survey was commissioned by the National Council for Community Behavioral Healthcare and AstraZeneca to better understand the impact of bipolar depression on people’s lives.

Bipolar disorder may affect approximately 8 million American adults.(2,3) People with bipolar disorder experience extreme mood swings from lows, called bipolar depression, to highs, called bipolar mania.(4) Many people with bipolar disorder report spending more time in the depressive phase(5) — which includes feelings of sadness and emptiness, depressed moods and inability to concentrate — than in the manic phase.(4) This fact was confirmed in the online survey, with 61 percent of people with bipolar disorder saying their depressive episodes last longer than their manic episodes.(1)

“This survey clearly demonstrates that many people with bipolar disorder are feeling the effects of bipolar depression in their day-to-day lives,” said Linda Rosenberg, president and CEO of the National Council for Community Behavioral Healthcare. “Bipolar disorder is a manageable disease, but there are a number of factors that can get in the way of successful treatment.”

In fact, the online survey revealed some communication challenges that people with bipolar disorder have with their physicians.(1) For example, forty-one percent of patients said they wished they could be more open about their bipolar depression symptoms with their health care professional.(1) In addition, 72% of physicians agreed that many of their patients don’t know how to accurately describe their bipolar depression symptoms.(1)

“Strong communication between patients and physicians is one of the most critical factors in effectively managing bipolar disorder,” said Rosenberg. “From a patient perspective, it’s important to share all symptoms and experiences so your doctor has a detailed picture of your day-to-day life. In turn, physicians can encourage patients to be true partners in developing an appropriate treatment plan to successfully manage their bipolar depression.”

Rosenberg also recommended the following steps for patients to strengthen communication with their health care professional:

– Describe how you’re feeling to the best of your ability. It’s OK if you don’t know the clinical language — just use your own words.

– Jot down any questions and concerns you have beforehand so you don’t forget them.

– Don’t hesitate to share anything and everything with your doctor, even if it feels personal or unimportant. Your doctor is best-equipped to help you when he or she has all the information.

– Work with your doctor to set expectations and goals for your treatment. For many patients, these may be “everyday” goals, like getting back to a regular work schedule or spending more time with family and friends.

About the Online Survey

The Bipolar Depression Treatment Dynamic was conducted by StrategyOne, an applied research consulting firm, on behalf of the National Council for Community Behavioral Healthcare and AstraZeneca. The online survey polled 2,005 American bipolar disorder patients (25 to 64 years of age) and 500 clinicians who treat patients with bipolar disorder (250 psychiatrists; 250 primary care physicians) to determine how they view the personal toll of depressive symptoms of bipolar disorder.(1) The online surveys, which for the patient sample had a margin of error of +/-2.2% and for the physician sample had a margin of error of +/-4.4%, were conducted using the field services of Harris Interactive Service Bureau from February 11, 2009, through February 27, 2009 and February 19, 2009, respectively.(1) As with all surveys of this type, this survey was not designed to be a scientific survey. Surveys of this type are by their nature limited due to potential sampling inconsistencies and other factors.

About the National Council for Community Behavioral Healthcare

The National Council for Community Behavioral Healthcare is a not-for-profit, 501(c)(3) association of 1,600 behavioral healthcare organizations that provide treatment and rehabilitation for mental illnesses and addictions disorders to nearly six million adults, children and families in communities across the country. The National Council and its members bear testimony to the fact that medical, social, psychological and rehabilitation services offered in community settings help people with mental illnesses and addiction disorders recover and lead productive lives

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing and marketing of prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in the gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease areas. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.

References

1. Data on file, 278295, AstraZeneca Pharmaceuticals LP.

2. US Bureau of the Census.

3. Hirschfeld RMA, Calabrese JR, Weissman MM, et al. Screening for Bipolar in the Community. J Clin Psychiatry. 2003; 64:53-59.

4. American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: APA; 2000.

5. Calabrese JR, Hirschfeld RMA, Frye MA, et al. Impact of Depressive Symptoms Compared with Manic Symptoms in Bipolar Disorder: Results of a U.S. Community-Based Sample. J Clin Psychiatry. 2004;65:1499-1504

Source: National Council for Community Behavioral Healthcare

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Mood disorders tend to cluster in families and research shows that bipolar disorder is a particularly inheritable form of mood disorder. Since the strongest risk factor for developing bipolar disorder is having one or more family members with the illness, identifying and treating children of bipolar parents has become an important focus for prevention efforts.

A research team led by Ellen Frank, Ph.D., distinguished university professor of psychiatry, University of Pittsburgh School of Medicine, and director of the Depression and Manic Depression Prevention Program at the Western Psychiatric Institute and Clinic of UPMC, and Tina Goldstein, Ph.D., assistant professor of psychiatry, University of Pittsburgh School of Medicine, is conducting a study to determine whether a specific type of talk therapy called Interpersonal and Social Rhythm Therapy (IPSRT), which was developed by Dr. Frank, will help to delay or even prevent the onset of bipolar disorder in children at risk for developing the illness due to a positive family history.

“We know that the chance that a person with a family history of bipolar disorder will develop the illness themselves increases with the biological closeness of the relationship,” noted Dr. Frank. “The children of parents with bipolar disorder are therefore a very high-risk group that requires our attention.”

Research has shown that if a child has one parent with bipolar disorder, the likelihood that he or she will develop the illness is between 5 and 10 percent. The risk can increase to about 15 percent if other relatives, such as siblings, aunts or uncles, are also affected. A child whose parents both have bipolar disorder is at a 30 percent higher risk of having the illness.

The IPSRT treatment approach is based on research showing that people with bipolar disorder, and those vulnerable to developing bipolar disorder, have especially sensitive circadian systems - meaning that disruptions in their sleep and social schedules, particularly during periods of stress, are associated with the onset of mood symptoms.

Normal shifts in sleep and social schedules occur during adolescence. Teens tend to want to stay up later at night and sleep in later in the morning. Yet, demanding school and social schedules often do not allow teens to get adequate sleep. The Pitt researchers believe that irregular schedules during adolescence, in combination with other risk factors, may increase the chances that an adolescent with a family history of bipolar disorder could develop mood symptoms. During treatment, a trained IPSRT therapist works together with the youth and family to improve stability in the teen’s daily schedules and sleep cycles and to help enhance his or her interpersonal relationships.

“The possibility that we may be able to prevent or delay this serious illness before its full expression is very exciting,” said Dr. Goldstein. “By intervening early, we hope to not only prevent the development of illness symptoms, but also decrease risk for other negative outcomes associated with bipolar disorder including academic, social and legal problems.”

Individuals with bipolar disorder who are the parents of a child between the ages of 12 and 18 who do not have bipolar disorder, may be eligible to participate in the study. Participation involves an initial assessment interview with parent and child and attendance at 10 to12 free weekly counseling sessions for up to three months. Interviews with parents and children also are conducted to evaluate mood symptoms. Families will be compensated for their participation.

Source
University Of Pittsburgh Medical Center

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