Schering-Plough’s schizophrenia relapse prevention trial meets primary endpoint

Asenapine, which is administered as a fast-dissolving sublingual tablet, is a psychopharmacologic compound with a unique human receptor signature, said Schering-Plough.

The study was a randomized, placebo-controlled, double-blind, multicenter, multinational clinical trial evaluating the efficacy and safety of sublingually administered asenapine (5 or 10mg BID) compared to placebo in the prevention of relapse in subjects with schizophrenia.

A total of 700 subjects entered the open-label treatment with asenapine for up to 26 weeks. Of these, a total of 386 subjects met criteria for stabilization on asenapine and were randomized to treatment in the 26-week double-blind placebo-controlled phase of the trial.

Asenapine was statistically significantly more effective than placebo in preventing relapse, the primary endpoint of the trial. Asenapine was generally well tolerated during the trial. Full results of the trial, including efficacy, safety and tolerability data will be presented later, the company said. These data are planned to be used to support a regulatory submission for the approval of asenapine in Europe.

Asenapine is currently under review by the FDA for the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar I disorder.