The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant Merck a marketing authorisation for Sycrest to treat moderate to severe manic episodes associated with bipolar I disorder in adults.
The committee did not support an indication for the treatment of schizophrenia.
Sycrest is an atypical anti-psychotic medication marketed by Merck as Saphris in the US.
Saphris was approved by the US Food and Drug Administration in August 2009 to treat acute schizophrenia in adults, as well as for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
The CHMP issued their opinion following a review of data supporting the efficacy, safety and tolerability of Sycrest in clinical trials involving more than 3,000 patients.
Merck anticipates a final European Commission decision regarding marketing authorisation for Sycrest in the third quarter of 2010.
