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RISPERDAL CONSTA (risperidone) l ...

Posted May 20 2009 10:18am

RISPERDAL CONSTA (risperidone) long-acting treatment delayed the time to relapse in patients with Bipolar I Disorder

SAN FRANCISCO, 20 may 2009 – New data demonstrate that maintenance therapy with RISPERDAL® CONSTA® (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® CONSTA® 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® CONSTA® for 26 weeks. In the double-blind phase, patients were randomized to either maintenance therapy with RISPERDAL® CONSTA® (N=154) or placebo (N=149). The median duration of treatment was nine months for patients in the RISPERDAL® CONSTA® 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® CONSTA® monotherapy as compared to placebo (p <0.001).>

The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increase (5% in monotherapy trial) and tremor and parkinsonism (≥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.

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