The Food and Drug Administration declined to clear Schering-Plough Corp’s experimental drug for schizophrenia and bipolar disorder, Saphris, the drugmaker reported on Wednesday.

 

The drug agency wanted more details from trials and also suggested labeling for the drug in complete response letter addressed to Schering-Plough. However, it did not ask for additional clinical trials for the drug. The company hopes to provide the requested data to the agency in the first quarter of this year.

 

Saphris, also known as asenapine, is a tablet used to treat schizophrenia and manic or mixed episodes linked to bipolar I disorder. The drug would be used by adults only. The FDA letter included proposed labeling for both uses, Schering-Plough said.

 

Saphris was acquired in November 2007 through the company’s acquisition of Organon BioSciences, which developed the drug. The application forwarded to the FDA includes data from a clinical trial involving more than 3,000 patients.

 

“We are pleased with the progress on the Saphris filing and look forward to working with the agency to address it request, finalize the product labeling and gain approval,” said Thomas Koestler, president of the Schering-Plough Research Institute.

 

If approved by the FDA, the drug could have sales exceeding 1 billion dollars a year, according to analysts.