Additionally, a preliminary pooled analysis of the combined data for these two identically designed studies showed a statistically significant treatment effect in favor of asenapine after one year of treatment.
These large Phase III studies were conducted following a previous Phase II study where favorable data on negative symptoms were observed for asenapine.
About the study
This study was a 26-week extension of a randomized, double-blind, multicentered, multinational 26-week clinical trial evaluating the efficacy and safety of SAPHRIS compared to olanzapine in the treatment of patients with stable predominant, persistent negative symptoms of schizophrenia. Patients were initially randomized in the core study to SAPHRIS 5 to 10 mg twice daily or olanzapine 5 to 20 mg once daily for 26 weeks. In the core study, both SAPHRIS and olanzapine reduced negative symptoms over the 26-week treatment period, but the difference between the two was not statistically significant. Patients who continued after six months were maintained on the same double-blind treatment regimen for the 26-week extension study. In the extension study, SAPHRIS demonstrated statistically significantly greater change in NSA-16 total score from the core study baseline after one year of treatment, the primary prespecified endpoint of the extension study. A total of 468 patients were randomized in the core study, 195 of whom entered the extension study, with 146 completing a total of one year of treatment.
In the study, the most common adverse events reported for the SAPHRIS group (greater than 5 percent) during the one year treatment period were: insomnia, somnolence, weight increase, anxiety, headache, weight decrease, akathisia, diarrhea, dizziness, fatigue, nasopharyngit
|SOURCE Schering-Plough Corporation|
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