KENILWORTH, N.J., Oct. 23 Schering-Plough Corporation (NYSE: SGP) today announced that its novel psychopharmacologic agent asenapine has met the primary endpoint in a long-term schizophrenia relapse prevention trial. Asenapine, which is administered as a fast-dissolving sublingual tablet, is a psychopharmacologic compound with a unique human receptor signature.
The study was a randomized, placebo-controlled, double-blind, multicenter, multinational clinical trial evaluating the efficacy and safety of sublingually administered asenapine (5 or 10 mg 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 at a later date. These data are planned to be used to support a regulatory submission for the approval of asenapine in Europe.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product. Asenapine is currently under review by the U.S. Food and Drug Administration for the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar I disorder.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to Earn Trust, Every Day with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for asenapine. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's 8-K filed Oct. 21, 2008.