Navigation Links
Schering-Plough Unveils Top-Line Study Results for SAPHRIS(TM) (asenapine) Demonstrating Efficacy in Long-Term Schizophrenia Relapse Prevention
Date:11/24/2008

Company's R&D Update Today Unveils Rich Development Pipeline of Compounds Meeting Important Medical Needs

KENILWORTH, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today revealed top-line results of a long-term Phase III clinical study of its psychopharmacologic agent SAPHRIS(TM) (asenapine) demonstrating efficacy and safety in preventing relapse of schizophrenia. In this trial, asenapine was statistically significantly more effective than placebo in preventing relapse, as measured by the primary endpoint of the trial estimated through Kaplan-Meier curves. At the 26 week endpoint, 47 percent of the placebo-treated patients relapsed, compared with only 12 percent of the asenapine-treated patients (p<0.0001). Asenapine was generally well tolerated, with somnolence and insomnia being the most frequently reported adverse events in the initial open-label treatment phase (occurring in more than 10 percent of patients).

The top-line data were presented today at the company's 2008 R&D Update meeting being hosted for analysts and portfolio managers at company headquarters. The company plans to submit results of the trial for presentation at a future medical meeting.

"Schizophrenia is a serious disease affecting millions of people worldwide, and there is a need for effective new medications with acceptable safety and tolerability profiles," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Asenapine is an important late-stage compound in the Schering-Plough development pipeline, and we are encouraged by the top-line data we are sharing today. We believe that asenapine may have the potential to help relieve the burden of schizophrenia."

Asenapine, administered as a fast-dissolving sublingual tablet, is a novel compound with a unique human receptor signature. Schering-Plough anticipates a filing for the approval of asenapine in Europe in 2009 for treatment of schizophrenia, and treatment of manic episodes associated with bipolar 1 disorder. Asenapine is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar I disorder. The company acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

The Phase III study was a placebo-controlled, double-blind, clinical trial with a randomized withdrawal design that evaluated the efficacy and safety of sublingually administered asenapine (5 or 10 mg BID) compared to placebo in the prevention of relapse in patients with schizophrenia. A total of 700 patients entered the open-label treatment with asenapine for up to 26 weeks. Of these, a total of 386 patients met criteria for stabilization on asenapine and were randomized to treatment in the 26-week double-blind placebo-controlled phase of the trial.

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 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 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 third quarter 2008 10-Q, filed Oct. 29, 2008.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
2. Schering-Plough Announces European Launch of BRIDION(R) (Sugammadex)
3. Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant
4. About 60 Clinical Studies Regarding Schering-Ploughs Oncology Compounds Will be Presented at ASCO
5. Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment
6. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting
7. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
8. Schering-Plough Announces Imperfect Contraceptive Use Impacts Womens Emotional Well-Being
9. Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infected Patients
10. Parker Waichman Alonso LLP and Affiliated Lawfirms Have Filed a Class Action Lawsuit in the United States District Court for the Eastern District of New York Against Merck & Co., Inc. and Schering-Plough Corporation
11. Schering-Plough Reports Top-Line Results of the IDEAL Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... 2017  Impax Laboratories, Inc. (NASDAQ: IPXL ) today announced ... Raymond James and Associates, 38 th ... in Orlando, FL. Cowen and ... on March 7, 2017 in Boston, MA. ... 2017 in Miami, FL. ...
(Date:2/27/2017)... Leading Countries, Technologies and Companies The ... a CAGR of 8.9% from 2016-2021 and CAGR of 9.2% from ... 9.1% from 2016 to 2027. The market is estimated at $816m ... ... on to discover how you can exploit the future business opportunities ...
(Date:2/27/2017)... October – December 2016 Revenues amounted to SEK 0.3 ... Result after tax amounted to SEK -16.3 (-6.5) million, corresponding ... Cash flow from operating activities amounted to SEK -8.3 (-7.3) million ... Period full year 2016 ... amounted to SEK -39.5 (-29.5) million Result after tax amounted ...
Breaking Medicine Technology:
(Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair Institute, ... announce an upgrade to the company's Yelp listing. Bay Area residents struggling from ... diverse as Platelet Rich Plasma (PRP) therapy, hair transplantation techniques such as Follicular ...
(Date:2/26/2017)... ... February 26, 2017 , ... Today, ... the 7th Edition of International Social Design Awards. , The 7th A' ... System Designers, Governments and Institutions worldwide with realized projects and conceptual works. , ...
(Date:2/26/2017)... New York, New York (PRWEB) , ... February ... ... of luxury baby products for wholesale distribution in North America, today announced it ... established online sites. The company, which prides itself on crafting quality and unique ...
(Date:2/26/2017)... ... ... ODH, Inc.™ announced today it will exhibit and speak at the ... in Arlington, VA. ODH’s director of medical strategy, Candace Saldarini, M.D., will present on ... health management. , ODH will also have an exhibit booth where attendees may speak ...
(Date:2/25/2017)... ... ... FCPX users now have the ability to sharpen a desired color range ... have total control over sharpening amount, sharpening radius, threshold, horizontal sharpening, vertical sharpening, and ... can visually see the color range effected with ease all within Final Cut ...
Breaking Medicine News(10 mins):