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Final results of SAPHRIS clinical study released

Published on September 14, 2009 at 7:51 AM · No Comments

Schering-Plough Corporation (NYSE: SGP) today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study. In the double-blind phase of the study, time to relapse or impending relapse, the primary efficacy endpoint, was significantly longer with SAPHRIS than with placebo (P < 0.0001). At the end of the double-blind phase, significantly fewer patients had relapsed with SAPHRIS than with placebo, 12 percent vs. 47 percent (P < 0.0001). In addition, the time to treatment discontinuation for any reason, a secondary efficacy assessment, was significantly longer with SAPHRIS than placebo (P < 0.001). These results were presented at a major European psychiatry congress in Istanbul, Turkey.

"Relapse rates can be high among patients with schizophrenia. Symptoms return in more than half of all patients by two years and in more than 80 percent by five years," said Steven Potkin, M.D., professor, department of psychiatry and human behavior, University of California, Irvine. "It is important that clinicians have new treatment options that not only effectively manage the symptoms of schizophrenia and are well tolerated by patients, but that also can help delay relapse."

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