EC backs Merck & Co's Sycrest for the treatment of manic episodes in bipolar I disorder

The European Commission has approved the Marketing Authorization Application for US drug giant Merck & Co's (NYSE: MRK) 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 (EMEA) Committee for Medicinal Products for Human Use (CHMP; The Pharma Letter June 28). The Commission decision applies to all 27 European Union member states. The indication was cleared in the USA last year.

"Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons," said Eduard Vieta, professor of psychiatry at the University of Barcelona, and director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, Spain, quoted by Merck. 'Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease," he added.

Clinical trial overview