Schering-Plough unveils top-line study results for Saphris (asenapine) demonstrating efficacy in long-term schizophrenia relapse prevention.

Schering-Plough Corp revealed top-line results of a long-term Phase III clinical study of its psychopharmacologic agent Saphris (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% of the placebo-treated patients relapsed, compared with only 12% of the asenapine-treated patients. Asenapine was generally well tolerated, with somnolence and insomnia being the most frequently reported adverse events in the initial open-label …