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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
Date:5/18/2009

RISPERDAL(R) CONSTA(R) is the First and Only Long-Acting Antipsychotic Therapy Available for Bipolar I Disorder

TITUSVILLE, N.J., May 18 /PRNewswire/ -- Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today 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 valpro
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SOURCE Janssen Pharmaceuticals
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