S-P's Saphris effective in schizophrenia relapse

US drug major Schering-Plough says that top-line results of a long-term Phase III study of its drug candidate Saphris (asenapine) demonstrated 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 subjects (p<0.0001). Asenapine was generally well tolerated, with somnolence and insomnia being the most frequently reported adverse events.

Acquired through the takeover of Dutch firm Organon (Marketletter November 26, 2007), asenapine is currently under review by US regulators and S-P plans to file for European approval in 2009 for the treatment of schizophrenia and manic episodes associated with bipolar 1 disorder.