Saphris (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Schizophrenia
KENILWORTH, N.J., July 24, 2009 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that its investigational agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia.
Negative symptoms of schizophrenia include apathy, lack of emotion and poor social functioning, among others. In the study, these symptoms were assessed using the validated 16-item Negative Symptom Assessment scale (NSA-16).
"These symptoms are among the most difficult to treat in the schizophrenia spectrum," said Armin Szegedi, M.D., Ph.D., vice president, global clinical research, central nervous system, Schering-Plough Research Institute. "Few studies with the antipsychotics currently available on the market have been designed specifically to evaluate long-term effects on predominant, persistent negative symptoms. The results from this large clinical study program will provide new insights into potential treatment of these symptoms."
In the study, SAPHRIS was significantly more effective than olanzapine in the reduction of negative symptoms as measured by change from baseline to Day 365 in the NSA-16 total score, the primary endpoint of the study. By using a mixed model for repeated measures (MMRM), least square mean changes in the NSA-16 total score were -15.8 for SAPHRIS vs. -11.0 for olanzapine (P=0.015). Full results of the trial, including efficacy, safety and tolerability data, will be submitted for presentation at a medical meeting at a later date.
These results follow those of a previously reported clinical trial in this patient population using the same study design and protocol in which both asenapine and olanzapine reduced negative symptoms after one year of treatment, but the difference between the two was not statistically significant.(1)
Additionally, a preliminary pooled analysis of the combined data for these two identically designed studies showed a statistically significant treatment effect in favor of asenapine after one year of treatment.
These large Phase III studies were conducted following a previous Phase II study where favorable data on negative symptoms were observed for asenapine.
About the study
This study was a 26-week extension of a randomized, double-blind, multicentered, multinational 26-week clinical trial evaluating the efficacy and safety of SAPHRIS compared to olanzapine in the treatment of patients with stable predominant, persistent negative symptoms of schizophrenia. Patients were initially randomized in the core study to SAPHRIS 5 to 10 mg twice daily or olanzapine 5 to 20 mg once daily for 26 weeks. In the core study, both SAPHRIS and olanzapine reduced negative symptoms over the 26-week treatment period, but the difference between the two was not statistically significant. Patients who continued after six months were maintained on the same double-blind treatment regimen for the 26-week extension study. In the extension study, SAPHRIS demonstrated statistically significantly greater change in NSA-16 total score from the core study baseline after one year of treatment, the primary prespecified endpoint of the extension study. A total of 468 patients were randomized in the core study, 195 of whom entered the extension study, with 146 completing a total of one year of treatment.
In the study, the most common adverse events reported for the SAPHRIS group (greater than 5 percent) during the one year treatment period were: insomnia, somnolence, weight increase, anxiety, headache, weight decrease, akathisia, diarrhea, dizziness, fatigue, nasopharyngitis, blood insulin increase, irritability, dry mouth and nausea.
Schering-Plough acquired SAPHRIS in November 2007 through its acquisition of Organon BioSciences, which developed the psychotropic agent. In the United States, a New Drug Application (NDA) for SAPHRIS sublingual tablets is currently under review by the U.S. Food and Drug Administration (FDA) and includes data from a clinical trial program involving more than 3,000 patients in bipolar mania and schizophrenia trials. In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST(R), is currently under review by the European Medicines Agency (EMEA).
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions and disordered thinking (often termed positive symptoms), and cognitive deficits, as well as negative symptoms such as apathy, avolition, diminished social drive, poverty of speech or curbing of interest, which are frequent disabling symptoms. About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia, including more than two million people in the United States and more than four million people in Europe.
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, animal health and consumer health care 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 clinical development of, the commercial plans for and the potential market for SAPHRIS/SYCREST. 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 uncertainties in 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 Part II, Item 1A. "Risk Factors" in the Company's first quarter 2009 10-Q, filed May 1, 2009.
(1) Cazorla P, Phiri P, den Hollander W, et al. Long-Term Treatment with Asenapine versus Olanzapine in Subjects with Predominant, Persistent Negative Symptoms of Schizophrenia. American College of Neuropsychopharmacology (ACNP) 47th Annual Meeting; Dec. 7-11, 2008; Scottsdale, AZ; No. 88.
SOURCE Schering-Plough Corporation
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Posted: July 2009