FDA issues complete response letter for SAPHRIS (asenapine) sublingual tablets in acute treatment of schizophrenia and bipolar disorder

Jan 15 2009

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

The action letter includes proposed labeling for both indications and a request for supplemental data from the existing asenapine database. No additional clinical trials have been requested. The Company anticipates providing the requested information to the agency in the first quarter of 2009.

"We are pleased with the progress on the SAPHRIS filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "New treatments are needed in this therapeutic area and we believe that asenapine has the potential to be an important option in addressing this need."

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the antipsychotic agent. The New Drug Application (NDA) for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.