Schering Plough has announced that the European Medicines Agency (EMEA) has validated the marketing authorization application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder.
The MAA for Sycrest includes data from the asenapine clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.
New Drug Application (NDA) for asenapine, under the brand name Saphris, is currently under review by the FDA for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.
Thomas Koestler, Executive Vice President and President at Schering-Plough Research Institute, said: We highlighted asenapine as one of the Five Stars in our late stage research and development pipeline at our R&D Update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009. I am pleased that we met this important milestone for asenapine within the first half of 2009.