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New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Schizophrenia
Date:12/17/2007

KENILWORTH, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported on new study results that demonstrated that Asenapine, a fast-dissolving, sublingual tablet being developed for treatment of schizophrenia, was more effective than placebo and well tolerated in treating patients with acute schizophrenia.

According to the results, asenapine 5 mg twice daily and 10 mg twice daily were both significantly more effective than placebo at improving patient Positive and Negative Syndrome Scale (PANSS) total scores. PANSS is a measure of positive symptoms (e.g., hallucinations and delusions) and negative symptoms (such as lack of emotion expression) associated with acute schizophrenia.

"Patients with schizophrenia and their physicians need to have a variety of treatment options available for the symptoms of this disorder because many patients stop taking their medication," said John M. Kane, M.D., Chairman of Psychiatry, the Zucker Hillside Hospital in Glen Oaks, NY. "A new therapy that is both effective and well-tolerated would be an important addition to the treatment options currently available."

Study overview

In the study, 448 adult patients with schizophrenia received either asenapine 5 mg twice daily, asenapine 10 mg twice daily, haloperidol 4 mg twice daily (active comparator), or placebo for six weeks. The primary endpoint was changes in PANSS total score from baseline to day 42.

PANSS score changes were significantly greater for asenapine 5 mg twice daily, asenapine 10 mg twice daily and haloperidol versus placebo (-21.3, - 19.4, -20.0 and -14.6, respectively) based on MMRM analysis (Mixed Model for Repeated Measurements). On secondary efficacy measures, asenapine 5
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SOURCE Schering-Plough Corporation
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