Saphris OK'd for schizophrenia

The drug is to be made available later this year and marketed under the name
Saphris, the Food and Drug Administration said.

Saphris is the first psychotropic drug to receive initial approval to treat both mental disorders, Schering-Plough officials said.

Saphris is the first product from Schering-Plough's 2007 acquisition of Organon Biosciences. It's FDA approval comes as Schering-Plough prepares to merge with Merck & Co., The Wall Street Journal reported Friday.

FDA approval of Saphris was based on a two-year clinical study of more than 3,000 patients with acute schizophrenia or bipolar mania. Its risks include sedation, weight gain, diabetes and a movement disorder known as tardive dyskinesia, FDA officials said.

Schizophrenia afflicts about 1 percent of U.S. residents while bipolar disorder, also known as manic-depressive illness, afflicts up to 3 percent of the population, the National Institute of Mental Health said.

Copyright 2009 by United Press International.