Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in theAcute Treatment of Both Schizophrenia and Bipolar I Disorder
Fri, 02/20/2009 - 5:33am
Schering-PloughCorporation today announced that it has responded to the FDA's complete response letter for SAPHRIS(TM)(asenapine) sublingual tablets, which was received in January 2009. SAPHRISis under review for the acute treatment of schizophrenia in adults and for theacute treatment of manic or mixed episodes associated with bipolar I disorderin adults as monotherapy. The action letter included proposed labeling for both indications and arequest for supplemental data from the existing asenapine database. Noadditional clinical trials were requested. "We are pleased to have submitted the SAPHRIS complete response within amonth from receipt of the FDA action letter. We look forward to working withthe agency to finalize labeling and gain approval, and to bringing a newtherapy to patients with schizophrenia and bipolar I disorder," said Thomas P.Koestler, Ph.D., executive vice president and president, Schering-PloughResearch Institute. Schering-Plough acquired asenapine in November 2007 through itsacquisition of Organon BioSciences, which developed the antipsychotic agent.The New Drug Application (NDA) for asenapine includes data from a clinicaltrial program involving more than 3,000 patients in schizophrenia and bipolarmania trials.