UPDATE:FDA:Saphris Safe,Effective For Schizophrenia, Bipolar

(Updates with additional information from FDA starting in the second paragraph.)

 
   By Jennifer Corbett Dooren 
   Of DOW JONES NEWSWIRES 
 

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Saphris, a proposed Schering-Plough Corp. (SGP) drug, was effective at treating schizophrenia and bipolar disorder in adults.

The agency, in a June 24 memo written by Thomas P. Laughren, the director of the FDA's division of psychiatry products, also said the safety profile of Saphris was "acceptable" and similar to other atypical antipsychotic drugs. The memo was posted on the FDA's Web site Tuesday. Laughren said the FDA hasn't made a final decision on whether to approve Saphris.

A separate memo said the data in support of short-term efficacy, or effectiveness, in treating schizophrenia "are not overwhelming for this drug." The FDA said data showing the effectiveness of Saphris in treating bipolar disorder were "sufficient."

Saphris faces a review on Thursday by an outside panel of medical experts. The panel is being asked to vote on whether it thinks the drug is safe and effective for the treatment of schizophrenia and bipolar disorder.

The FDA said although there are a number of drugs approved to treat such conditions, that "having multiple treatment options is important" because not all patients respond to or tolerate available drugs. But the agency said 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 movement disorder called tardive dyskinesia.

Background memos released by the agency also show that one medical reviewer, Ronald E. Kavanagh, didn't think Saphris should be approved because of "potentially cardiac and respiratory toxicities." Kavanagh raised his concerns in an email to other reviewers and certain FDA supervisors in May 2008.

However, another memo written by Thomas Laughren, dated Aug. 1, 2008, said Kavanagh's concerns on various safety issues "are difficult to address because they are wide-ranging in scope and often unsupported by specific data."

The FDA issued a so-called complete response letter in January asking Schering-Plough for more data, which the company supplied earlier this year.

During the panel meeting Thursday, officials from Schering-Plough will present data in support of Saphris. Laughren said in his memo the FDA won't make its own presentation during the meeting, "since we are in essential agreement with the data being presented by the sponsor." The FDA typically makes its own presentation during advisory panel meetings.

Schizophrenia afflicts about 1% of Americans. 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.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

(END) Dow Jones Newswires

July 28, 2009 11:43 ET (15:43 GMT)

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