Sycrest approved in EU for bipolar 1 disorder and FDA extends indications

EMA has approved the Marketing Authorization Application for Sycrest (asenapine) sublingual tablets from Merck Inc./MSD for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The drug is not EU approved for schizophrenia but has both approvals in USA. Sycrest is known as Saphris in the USA. Merck announced on 11/9/2010 that the FDA has approved two supplemental new drug applications for Saphris (asenapine) sublingual tablets. Saphris is now indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Saphris was initially approved by the FDA on 13/8/2009 for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.