Schering-Plough announced FDA approval on a key pipeline antipsychotic today, and is building a US sales force for the Q4 launch.

The product, Saphris (asenapine), received approval on two indications: for the acute treatment of schizophrenia in adults, and the acute treatment of manic or mixed episodes associated with bipolar 1 disorder. Saphris represents Schering’s first entry into the CNS therapeutic area.

“Saphris is a five star pipeline drug that we have highlighted for investors, and was a major reason for Schering’s acquisition of Organon BioSciences [in late 2007],” said Bob Consalvo, a Schering spokesperson. Saphris is the first Organon/Schering product approved in the US.

Consalvo noted that Schering’s specialty sales force will handle Saphris, as opposed to its primary cast of reps, but declined to speculate about headcount. Schering has an “interest in CNS,” with other products in earlier stages of development for conditions like Parkinson’s disease, said Consalvo. Campaign materials for Saphris are currently in development. The brand site is located at

A Marketing Authorization Application (MAA) for asenapine, under the brand name Sycrest, is currently under review by the European Medicines Agency (EMEA) in Europe, according to a company release.