DOW JONES NEWSWIRES
The Food and Drug Administration gave final approval to
Schering-Plough Corp.'s (SGP) asenapine, a treatment for both
schizophrenia and bipolar disorder in adults.
The drug, which will be sold under the brand name Saphris, is
expected to be available in the U.S. in the fourth quarter.
The company said it is the first psychotropic drug to receive
initial approval to treat both mental disorders and is the first
product from its 2007 acquisition of Organon Biosciences.
The approval comes as Schering-Plough is poised to merge with
Merck & Co. (MRK), after shareholders at both companies
approved the deal last week.
The FDA decision was based on a clinical study involving more
than 3,000 patients with acute schizophrenia or bipolar mania, with
patients followed for as long as two years.
Saphris and other so-called atypical antipsychotic drugs all
have "significant risks" including sedation, weight gain, and, over
time, concerns about diabetes and other conditions linked to weight
gain. The drugs can also cause a serious movement disorder called
tardive dyskinesia.
Schizophrenia afflicts about 1% of Americans and is a major
contributor to suicide. According to the National Institute of
Mental Health, people with schizophrenia may hear voices other
people don't hear or they may believe that others are reading their
minds, controlling their thoughts or plotting to harm them.
Bipolar disorder, also known as manic-depressive illness, is
believed to affect about 1% to 3% of the U.S. population.
Schering-Plough shares are up 0.7% premarket at $27.29. The
shares are up by a third in the past year.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
tess.stynes@dowjones.com