Schering-Plough will provide additional data during this quarter.
FDA has asked Schering-Plough for supplemental data from an existing database and proposed labeling for Saphris sublingual tablets. The labeling details cover both indications in the NDA: acute treatment of schizophrenia in adults and in acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
No additional clinical trials have been requested. Schering-Plough anticipates providing the requested information to the agency this first quarter.
Schering-Plough acquired asenapine in November 2007 through its $14 billion takeover of Organon BioSciences, which developed the antipsychotic agent. The NDA for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.