According to the results, asenapine 5 mg twice daily and 10 mg twice daily were both significantly more effective than placebo at improving patient Positive and Negative Syndrome Scale (PANSS) total scores. PANSS is a measure of positive symptoms (e.g., hallucinations and delusions) and negative symptoms (such as lack of emotion expression) associated with acute schizophrenia.
"Patients with schizophrenia and their physicians need to have a variety of treatment options available for the symptoms of this disorder because many patients stop taking their medication," said John M. Kane, M.D., Chairman of Psychiatry, the Zucker Hillside Hospital in Glen Oaks, NY. "A new therapy that is both effective and well-tolerated would be an important addition to the treatment options currently available."
Study overview
In the study, 448 adult patients with schizophrenia received either asenapine 5 mg twice daily, asenapine 10 mg twice daily, haloperidol 4 mg twice daily (active comparator), or placebo for six weeks. The primary endpoint was changes in PANSS total score from baseline to day 42.
PANSS score changes were significantly greater for asenapine 5 mg twice daily, asenapine 10 mg twice daily and haloperidol versus placebo (-21.3, - 19.4, -20.0 and -14.6, respectively) based on MMRM analysis (Mixed Model for Repeated Measurements). On secondary efficacy measures, asenapine 5 mg and 10 mg, and haloperidol produced significantly greater reductions in PANSS positive subscale score vs. placebo (-7.5, -6.9 and -7.3 vs. -5.0, respectively). In addition, asenapine 5 mg and 10 mg, and haloperidol demonstrated significant changes to the PANSS negative subscale score vs. placebo (-4.5, -4.3 and -4.2 vs. -3.0, respectively) and on the PANSS general psychopathology subscale score (-9.6, -8.5 and -8.6 vs. -6.8, respectively).
Significantly more patients on both asenapine 5 mg and 10 mg, and haloperidol demonstrated reductions in PANSS total score of greater than or equal to 30 percent (PANSS responders) vs. placebo (55 percent, 49 percent and 43 percent vs. 33 percent, respectively). Changes on the Clinical Global Impression-Severity of Illness (CGI-S) scale for asenapine 5 mg and 10 mg, and haloperidol were higher than for placebo (-1.2 , -1.1 and -1.2 vs. -0.8, respectively).
The most commonly reported adverse events (AEs) were insomnia, oral hypoesthesia (reduced sense of touch), and akathisia (restlessness) for asenapine (for both doses); akathisia, Parkinson-like symptoms, and insomnia for haloperidol. The incidence of clinically-significant weight gain, as well as changes in lipid and blood-sugar levels in this trial were small and not different among the treatment groups and placebo. The incidence of extrapyramidal symptoms reported as an adverse event was 15 percent and 18 percent for asenapine (5 and 10 mg, respectively), 34 percent for haloperidol, and 10 percent for placebo.
About schizophrenia
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions, and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia (1), including more than two million people in the U.S. (2) and more than four million people in Europe (3). People with schizophrenia may hear voices other people don't hear or may believe others are trying to harm them. As a result, they may become socially withdrawn, fearful, and agitated (2).
Schering-Plough acquired asenapine through its combination with Organon BioSciences on November 19, 2007.
About Schering Plough
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. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://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 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 market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in the company's third quarter 2007 10-Q.
References
(1) World Health Organization. Available online at:
(2) National Institute of Mental Health. Available online at:
(3) World Health Organization. WHO European Ministry Conference on Mental Health.
Schering-Plough Corporation
http://www.schering-plough.com