Back in April, asenapine missed a primary endpoint. Schering-Plough's solution? Run it longer, and add some longer term measures, all to prepare for the FDA Advisory Committee session on July 30, 2009.
Take a look:
. . . . 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 olanzapine reduced negative symptoms after one year of treatment, but the difference between the two was not statistically significant. . . .
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. . . .