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.