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."

Source: schering-plough