Schering-Plough has won FDA approval of Saphris, a likely blockbuster antipsychotic, just ahead of its acquisition by Merck. The drug is now approved to treat episodes related to bipolar I disorder as well as acute schizophrenia.
The drug--asenapine--targets receptors in the brain, much as current antipsychotics do. But Saphris has been able to work without spurring some of the severe side effects, such as weight gain, that patients taking other drugs in the same class have experienced. That safety profile is expected to push annual sales above a billion dollars a year, making today's approval a big win for Merck. Saphris will now go up against Risperdal from J&J and Zyprexa from Eli Lilly.
"Having a new FDA-approved treatment such as Saphris is important in these serious conditions because physicians need options to help manage their patients' symptoms," said Roger S. McIntyre, M.D., associate professor of psychiatry and pharmacology, University of Toronto, Canada, and lead author of the pivotal bipolar mania studies as part of the Saphris clinical development program.
- read the Schering release
- check out the Reuters story