S-P's asenapine meets primary endpoint schizophrenia relapse trial

US drug major Schering-Plough's novel psychopharmacologic agent asenapine met the primary endpoint in a long-term schizophrenia relapse prevention trial. Administered as a fast-dissolving sublingual tablet, the agent has a unique human receptor signature, the firm noted. In the randomized, placebo-controlled, double-blind, multicenter, multinational clinical trial evaluating the efficacy and safety of sublingually administered asenapine (5mg or 10mg) 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. The drug was statistically-significantly more effective than placebo in preventing relapse, the primary endpoint of the trial and was generally well tolerated during the trial.