Schering-PloughCorporation has announced that its investigational agentSAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment inan extension study in patients with predominant, persistent negative symptomsof schizophrenia. Negative symptoms of schizophrenia include apathy, lack of emotion andpoor social functioning, among others. In the study, these symptoms wereassessed using the validated 16-item Negative Symptom Assessment scale(NSA-16). “These symptoms are among the most difficult to treat in the schizophreniaspectrum,” said Armin Szegedi, M.D., Ph.D., vice president, global clinicalresearch, central nervous system, Schering-Plough Research Institute. “Fewstudies with the antipsychotics currently available on the market have beendesigned specifically to evaluate long-term effects on predominant, persistentnegative symptoms. The results from this large clinical study program willprovide new insights into potential treatment of these symptoms.” In the study, SAPHRIS was significantly more effective than olanzapine inthe reduction of negative symptoms as measured by change from baseline to Day365 in the NSA-16 total score, the primary endpoint of the study. By using amixed model for repeated measures (MMRM), least square mean changes in theNSA-16 total score were -15.8 for SAPHRIS vs. -11.0 for olanzapine (P0.015).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 thispatient population using the same study design and protocol in which bothasenapine and olanzapine reduced negative symptoms after one year oftreatment, but the difference between the two was not statisticallysignificant. Additionally, a preliminary pooled analysis of the combined data for thesetwo identically designed studies showed a statistically significant treatmenteffect in favor of asenapine after one year of treatment. These large Phase III studies were conducted following a previous Phase IIstudy where favorable data on negative symptoms were observed for asenapine.About the study
