SAPHRIS(R) (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Sch...( ...)

KENILWORTH, N.J., July 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that its investigational agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia.

Negative symptoms of schizophrenia include apathy, lack of emotion and poor social functioning, among others. In the study, these symptoms were assessed using the validated 16-item Negative Symptom Assessment scale (NSA-16).

"These symptoms are among the most difficult to treat in the schizophrenia spectrum," said Armin Szegedi, M.D., Ph.D., vice president, global clinical research, central nervous system, Schering-Plough Research Institute. "Few studies with the antipsychotics currently available on the market have been designed specifically to evaluate long-term effects on predominant, persistent negative symptoms. The results from this large clinical study program will provide new insights into potential treatment of these symptoms."

In the study, SAPHRIS was significantly more effective than olanzapine in the reduction of negative symptoms as measured by change from baseline to Day 365 in the NSA-16 total score, the primary endpoint of the study. By using a mixed model for repeated measures (MMRM), least square mean changes in the NSA-16 total score were -15.8 for SAPHRIS vs. -11.0 for olanzapine (P=0.015). Full results of the trial, including efficacy, safety and tolerability data, will be submitted for presentation at a medical meeting at a later date.

These results follow those of a previously reported clinical trial in this patient population using the same study design and protocol in which both asenapine and olanzapi
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