Merck announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the pending Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.
“We are pleased that, pending a final Commission decision, physicians in European markets may have a new option to help their patients manage the symptoms of bipolar I disorder”
SYCREST is an atypical antipsychotic medication that Merck markets as SAPHRIS® (asenapine) sublingual tablets in the United States. SAPHRIS was approved by the FDA on August 13, 2009 with indications for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
"We are pleased that, pending a final Commission decision, physicians in European markets may have a new option to help their patients manage the symptoms of bipolar I disorder," said Armin Szegedi, M.D., head of Psychiatry, Neuroscience Clinical Research, Merck.
The CHMP issued their opinion following a review of data supporting the efficacy, safety and tolerability of SYCREST from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The MAA for SYCREST is following the Centralized Procedure. Merck anticipates receiving a final European Commission Decision regarding marketing authorization for SYCREST in the third quarter of 2010. The Commission Decision will apply to all 27 European Member States. Concurrently, Merck is continuing to pursue regulatory approval for asenapine in other parts of the world.
SAPHRIS Efficacy in Bipolar I Disorder and Schizophrenia
The FDA approval of SAPHRIS in the United States was based on a New Drug Application that included data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The U.S. approval was based on acute schizophrenia trials in which SAPHRIS (5 mg twice daily) demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which SAPHRIS (10 mg twice daily) demonstrated a statistically significant reduction of bipolar mania symptoms versus placebo.