FDA Panel Says Saphris Effective At Treating Schizophrenia
31 July 2009 - 4:46AM
Dow Jones News
A U.S. Food and Drug Administration panel said Thursday
asenapine, a proposed Schering-Plough Corp. (SGP) drug, was
effective at treating schizophrenia.
The panel is currently voting on whether it thinks asenapine,
which would be sold under the brand name Saphris, is "acceptably"
safe and effective for treating schizophrenia and bipolar
disorder.
The panel voted 10 to 2 in favor of a question that asked if the
Saphris has been shown to be effective for the acute treatment of
adult schizophrenia. The company is also seeking FDA approval to
market the drug as a treatment for bipolar disorder.
Schizophrenia is a mental disorder that 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.
Thomas P. Laughren, the director of the FDA's division of
psychiatry products, said although the FDA hasn't reached a final
conclusion on whether to approve Saphris, "in general we are in
agreement that the sponsor has shown the drug is effective for
these indications."
Laughren said 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. Still, he said schizophrenia
and bipolar are serious disorders that need new treatment options
because not all patients respond well or tolerate individual
drugs.
An FDA memo released in advance of the meeting said the data in
support of Saphris' short-term efficacy, or effectiveness, in
treating schizophrenia "are not overwhelming for this drug."
During the panel meeting, officials from Schering-Plough
presented data from three studies involving Saphris in
schizophrenia patients, which showed that one study was negative
and two were positive in favor of Saphris.
The FDA said data showing the effectiveness of Saphris in
treating bipolar disorder were "sufficient."
The FDA typically brings applications for new types of drugs to
its advisory panels of outside medical experts for review before
taking final action.
Schering-Plough shares are up nearly 1% to $26.78.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com