Schering-Plough Receives FDA Approval For SAPHRIS

FDA has approved Schering-Plough’s SAPHRIS (asenapine) sublingual tablets for acute treatment of schizophrenia and manic or mixed episodes, associated with bipolar I disorder with or without psychotic features, in adults. SAPHRIS can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously.

Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: We are very pleased with the US approval of SAPHRIS, which represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment. SAPHRIS is an important addition to Schering-Plough’s product portfolio, and represents the first US approval resulting from the Organon/Schering-Plough combination.

The FDA approval of SAPHRIS is based on a New Drug Application (NDA) that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The SAPHRIS filing was supported by safety data in 4,500 people, with some patients treated for more than two years. The approval is based on acute schizophrenia trials in which SAPHRIS (5mg twice daily) demonstrated efficacy versus placebo, and acute bipolar I disorder studies in which SAPHRIS (10mg twice daily) demonstrated reduction of bipolar mania symptoms versus placebo.

SAPHRIS is expected to be available in the US during the fourth quarter of 2009.