Navigation Links
Video: Schering-Plough Announces FDA Approval of SAPHRIS(R) (asenapine) for Acute Treatment of Schizophrenia In Adults and Manic or Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features In Adults
Date:8/14/2009

partment of psychiatry and human behavior, University of California, Irvine, and lead author of a pivotal schizophrenia study as part of the SAPHRIS clinical development program.

"Having a new FDA-approved treatment such as SAPHRIS is important in these serious conditions because physicians need options to help manage their patients' symptoms," said Roger S. McIntyre, M.D., associate professor of psychiatry and pharmacology, University of Toronto, Canada, and lead author of the pivotal bipolar mania studies as part of the SAPHRIS clinical development program.

The FDA approval of SAPHRIS is based on a New Drug Application (NDA) that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The SAPHRIS filing was supported by safety data in 4,500 people, with some patients treated for more than two years. The approval is based on acute schizophrenia trials in which SAPHRIS (5 mg twice daily) demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which SAPHRIS (10 mg twice daily) demonstrated statistically significant reduction of bipolar mania symptoms versus placebo.

About SAPHRIS (asenapine)

SAPHRIS is a psychotropic agent indicated for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Schering-Plough has reported additional top-line results for SAPHRIS in long-term clinical studies. Additional clinical studies with SAPHRIS are ongoing.

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) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Pro
'/>"/>

SOURCE Schering-Plough
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine news :

1. Video: Nutrition Comes to NASCAR
2. Video: Circulatory Care of New Jersey
3. Video: GEN Video Hits Home with Web Audience
4. Video: Beyond the Red Door: Gildas Club Worldwide and DKNY Host Successful Benefit Event
5. Video: Food Expert B. Smith to Provide Healthy Menu Makeovers
6. Video: New FDA-Approved Sun Protectant Saves Skin All Year Round
7. Video: Kyphon Supports World Osteoporosis Day on October 20, 2007 to Raise Awareness of Osteoporosis and Spinal Fracture Risk
8. Video: Trinity Mother Frances Neurosurgeon First in Region to Remove Brain Tumor Using Unique Surgical Procedure
9. Video: Holiday Safety Is Important
10. Video: Grin Big With an Award-Winning Smile
11. Video: BSP Pharma Inc. Announces Groundbreaking Findings from The Australian Centre for Complementary Medicine Education and Research Joint Health Clinical Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... July 31, 2014 Bedford Commons ... firm Innerspire: Brand ReEnergizers to do what ... how we connect with the community all while still ... area practice, which caters to women’s health needs for ... and total women focused care ( Gynecology ), worked ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 Dr. Andrew ... American Board of Dermatology, fellowship trained Mohs surgeon that ... Top Docs. , After extensive dermatology research training at ... Health, Dr. Li completed his internship in internal medicine ... University of Pennsylvania in Philadelphia. Dr. Li pursued further ...
(Date:7/31/2014)... has been rising steadily in the U.S in recent ... and Health, the number of individuals reporting past year ... (669,000). Emerging evidence suggests the increase may be linked ... and/or intranasal PO use to heroin use, with POs ... heroin injection. This drug-use trajectory appears to have ...
(Date:7/31/2014)... 2014 Model moms are believers. PBS has ... positions in the field have grown exponentially in the last ... thriving industry, there are associated myths that need to be ... Frontier Nursing University . Celebrating 75 years in 2014, ... in the nation. “Frontier is changing the face of ...
(Date:7/31/2014)... Infection prevention and control is the ... products in the pharma, medical device, and food industries. ... products and equipment types; the two procedures prevent the ... products. , The world market for infection prevention ... a CAGR of about 7.5% through to 2018. The ...
Breaking Medicine News(10 mins):Health News:Doctor Videos & Women’s Stories Jumpstart Local OB-GYN Practice 2Health News:Doctor Videos & Women’s Stories Jumpstart Local OB-GYN Practice 3Health News:Doctor Videos & Women’s Stories Jumpstart Local OB-GYN Practice 4Health News:NJ Top Docs Proudly Presents Approved Provider, Dr. Andrew Li of Warren Skin Care Center 2Health News:NYU CDUHR researchers look at prescription opioid abuse among young adults in NYC 2Health News:NYU CDUHR researchers look at prescription opioid abuse among young adults in NYC 3Health News:Frontier Nursing University Busts Midwifery Myths In Celebration of 75th Anniversary 2Health News:Frontier Nursing University Busts Midwifery Myths In Celebration of 75th Anniversary 3Health News:Frontier Nursing University Busts Midwifery Myths In Celebration of 75th Anniversary 4Health News:Frontier Nursing University Busts Midwifery Myths In Celebration of 75th Anniversary 5Health News:Infection Prevention and Control Market to Post about 7.5% CAGR through 2018, States Infiniti Research in Its Study Published at MarketPublishers.com 2Health News:Infection Prevention and Control Market to Post about 7.5% CAGR through 2018, States Infiniti Research in Its Study Published at MarketPublishers.com 3
... from across Pennsylvania with substantial experience in ... Sept. 11 The Pennsylvania,Patient Safety Authority,s Board ... control experts to help implement Act 52 of ... Ed Rendell in July to help reduce and,eliminate ...
... Sally Watkins, PhD(c), MS, RN, has been named ... the Washington State Nurses,Association (WSNA), the State,s oldest ... are very fortunate to have in Sally Watkins ... and nurse advocate," said WSNA Executive,Director Judy Huntington, ...
... a mid-August edition of Circulation: Journal of the America Heart ... eating habits, it can strongly influence their heart disease risk ... Coronary Risk Factor Intervention Project have landmark implications on how ... a childs fat intake, primarily reduction in intake of saturated ...
... power industry is riding the green wave back into ... to our growing energy needs. But even as the ... play, it is bound by a global energy landscapefrom ... the marketplace. , Veteran New York Times energy ...
... shows no improvement with carvedilol , , TUESDAY, Sept. 11 (HealthDay News) ... that has been effective for adults with heart failure, did not ... rate of improvement -- and the lack of it -- was ... drug as it was for 54 youngsters who got a placebo. ...
... of prostate biopsies resulted in a cancer diagnosis among ... first biopsy did not find cancer often had multiple ... a cancer diagnosis. , While PSA (prostate-specific antigen) ... a biopsy is what actually determines the presence of ...
Cached Medicine News:Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 2Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 3Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 4Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 5Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 6Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 7Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 8Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 9Health News:New Director of Nursing Practice Named for Nurses Association 2Health News:Children who learn heart healthy eating habits lower heart disease risk 2Health News:Children who learn heart healthy eating habits lower heart disease risk 3Health News:Trade-offs reveal no clear favorites in alternative energy market 2Health News:Beta Blocker Doesn't Help Children With Heart Failure 2Health News:Other highlights in the September 11 JNCI 2Health News:Other highlights in the September 11 JNCI 3
(Date:7/31/2014)... SAN DIEGO, July 31, 2014 Tandem Diabetes Care®, ... and manufacturer of the t:slim® Insulin Pump, today reported its ... In comparing the second quarter of 2014 to ... percent to $10.3 million from $5.5 million , t:slim ... pumps In comparing six months ended June 30, ...
(Date:7/31/2014)... , July 31, 2014  Alexza Pharmaceuticals, Inc. ... update on its pipeline and new product development ... to initiate a Phase 2a study of AZ-002 ... for the management of patients with acute repetitive ... Staccato -based product candidates for development - AZ-008 ...
(Date:7/31/2014)... July 31, 2014  Decision Resources Group is launching ... product Marketrack to now include ChinaTrack; the new capabilities ... in an interactive dashboard providing detailed brand-level share tracking ... a hospital level. Other key capabilities of ... feed: In addition to end-user surveys of healthcare facilities, ...
Breaking Medicine Technology:Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 2Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 3Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 4Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 5Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 6Alexza Provides Pipeline Update 2Alexza Provides Pipeline Update 3Alexza Provides Pipeline Update 4Alexza Provides Pipeline Update 5Alexza Provides Pipeline Update 6Decision Resources Group Announces First Medical Device Account Targeting Tool in China 2
Remote Alpha Dock system for the DNA Engine line, allows, Alpha unit to function remotely (requires fan power supply)...
Reads single TrakMates tubes instantly, and drops decoded tube number instantly into any Windows application. System includes reader and Windows based software....
Round, height-adjustable, steel laboratory stools with small footprint for small spaces • Choose options like different height-adjustment mechanism or paint finish. • your choice of color...
... acrylic panels mounted on powder-coated ... a free-standing modular cleanroom that ... 3. Optional ceiling HEPA filter/fan ... configured to customer requirements. Negative-pressure ...
Medicine Products: