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Capsules effective in treating acute manic and mixed episodes of Bipolar I Disorder

Shire Pharmaceuticals Inc. has announced that University of North Carolina at Chapel Hill researchers studied the efficacy of carbamazepine extended-release capsules (CBZ-ERC, Equetro) in patients with manic or mixed episodes of Bipolar I Disorder over six months. Data from this open label study was presented by UNC researchers last week at the 18th annual U.S. Psychiatric and Mental Health Congress in Las Vegas.

These data complement a pooled analysis of data from two, three-week placebo-controlled phase 3 studies of CBZ-ERC, which demonstrated that CBZ-ERC significantly reduced manic and mixed symptoms for patients and was generally well tolerated. CBZ-ERC, manufactured for Shire US Inc., is the only formulation of carbamazepine approved by the U.S. Food and Drug Administration for treatment of patients with acute manic and mixed episodes associated with Bipolar I Disorder. Shire provided funding for these studies.

Many patients still fail to find an effective medication for their bipolar disorder that is generally well tolerated with a low incidence of weight gain, which can influence their ability to stay on treatment, said Richard H. Weisler, M.D., primary investigator of both clinical trials and adjunct professor of psychiatry at UNCs School of Medicine. A medication like CBZ-ERC that works effectively and is well tolerated in both manic and mixed patients is a very important addition to our treatment options for patients and their doctors.

Weisler also is an adjunct assistant professor of psychiatry and behavioral sciences at Duke University Medical Center and has a private practice in Raleigh.

As many as 450 million people suffer from a mental or behavioral disorder worldwide, according to the World Health Organization. A recent study demonstrated that Bipolar I Disorder is more prevalent in the U.S. than previously estimated, affecting approximately 2 percent of the population annually and 3.3 percent of the population i
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Contact: Matthew Cabrey
484-595-8248
Porter Novelli
16-Nov-2005


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