Schering-Plough (SGP) Unveils Top-Line Results on SAPHRIS(TM) Showing Efficacy and Safety in Preventing Relapse of Schizophrenia; Reports Preladenant Met Primary Endpoints in Phase II Trial

November 24, 2008 10:48 AM EST

Schering-Plough Corporation (NYSE: SGP) today revealed top-line results of a long-term Phase III clinical study of its psychopharmacologic agent SAPHRIS(TM) (asenapine) demonstrating efficacy and safety in preventing relapse of schizophrenia. In this trial, asenapine was statistically significantly more effective than placebo in preventing relapse, as measured by the primary endpoint of the trial estimated through Kaplan-Meier curves. At the 26 week endpoint, 47 percent of the placebo-treated patients relapsed, compared with only 12% of the asenapine-treated patients (p<0.0001). Asenapine was generally well tolerated, with somnolence and insomnia being the most frequently reported adverse events in the initial open-label treatment phase (occurring in more than 10% of patients).

The top-line data were presented today at the company's 2008 R&D Update meeting being hosted for analysts and portfolio managers at company headquarters. The company plans to submit results of the trial for presentation at a future medical meeting.

Separately, reported that preladenant, its novel and selective adenosine2a receptor antagonist, met the primary endpoint in a Phase II dose-finding trial in patients suffering from moderate to severe Parkinson's disease experiencing motor fluctuations and abnormal involuntary movements.

Schering-Plough Corporation discovers, develops, manufactures, and sells pharmaceuticals worldwide.

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