Final results of SAPHRIS clinical study released

Sep 14 2009

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."

SAPHRIS was approved by the U.S. Food and Drug Administration (FDA) on August 13 for the acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. SAPHRIS can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously. In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST(R), is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure. These long-term relapse prevention data are included in the European application and will be submitted to FDA in a supplemental application. Schering-Plough has reported additional top-line results for SAPHRIS in long-term clinical studies and additional clinical studies with SAPHRIS are ongoing.

"Schizophrenia is a serious, debilitating disease affecting millions of people worldwide, and there is a need for effective new medications," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "These results provide important new data for SAPHRIS and provide physicians insight into the treatment of patients responding to SAPHRIS."