Schering-Plough has revealed final results of a Saphris long-term schizophrenia relapse prevention clinical study. In the double-blind phase of the study, time to relapse or impending relapse, the primary efficacy endpoint was significantly longer with Saphris than with placebo. The secondary efficacy assessment, was longer with Saphris than placebo.
Saphris is a psychotropic agent approved in the US for the acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. The recommended starting dose of Saphris for the acute treatment of schizophrenia is 5mg sublingually twice daily.
The company said that the phase3 relapse prevention study was a placebo controlled, double-blind, clinical trial with a randomised withdrawal design that evaluated the long-term efficacy and safety of a sublingually administered investigational dose of Saphris compared to placebo in prolonging time to relapse or impending relapse in patients with stable schizophrenia.
A total of 700 patients entered open-label treatment with Saphris for up to 26 weeks. Of these, a total of 386 patients met criteria for stabilisation on Saphris and were randomised to treatment in the 26-week double-blind, placebo-controlled phase of the trial.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: “These results provide important new data for SAPHRIS and provide physicians insight into the treatment of patients responding to Saphris.”