FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Sch...( ...),Health

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these indications.

"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for SAPHRIS," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "In clinical studies, SAPHRIS has demonstrated efficacy combined with an attractive metabolic safety profile. SAPHRIS has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring SAPHRIS to the U.S. market as soon as possible so that patients can benefit from this new medication."

While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing the SAPHRIS data, the committee voted in favor of SAPHRIS as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and
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