MSD (MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A). announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.
“Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease.”
"Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons," said Eduard Vieta, M.D., Ph.D., professor of psychiatry at the University of Barcelona, and director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, Spain. "Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease."
The European Commission approval of SYCREST, an atypical antipsychotic, for the treatment of manic episodes in bipolar I disorder, was based on a review of efficacy data from a clinical trial program, which included nearly 1,300 patients with bipolar mania. SYCREST is marketed as SAPHRIS® (asenapine) sublingual tablets in the United States.