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:3/1/2015)... CrossFit Attollo is a CrossFit gym located in Vancouver ... to new members. Now through the end of March ... will receive their fourth month half off. , ... The three month contract is only $264, dropping the price ... comes in at only $55. The special saves new members ...
(Date:2/28/2015)... 2015 In a recent episode of ... Game Change Athlete Development Services and Consultancy ... benefits of athlete development and player engagement during and ... challenges that athletes face and how off-field activities are ... Fletcher became involved in athlete development issues while in ...
(Date:2/28/2015)... Portland, Oregon (PRWEB) February 28, 2015 ... Portland, Oregon, is offering a new special. Throughout ... denture relines. , This service ... from sleep problems and pain. Patients may notice certain ... and need relining. These symptoms include: , 1.    Pain, ...
(Date:2/28/2015)... Indosoft Inc , developers of ... are pleased to announce the development of Q-Suite 5.9. ... versions of Q-Suite, this new version will include enhancements ... new features to the leading edge call center software. ... will add features to enhance security and protection. Administrators ...
(Date:2/28/2015)... Pioneer Millworks reclaimed USA wood will be ... Materials Show, an annual, premier sustainable building event in ... top manufacturers of the latest building products, services and ... and manufactured by Pioneer Millworks from their Oregon and ... restaurants, hotels, retailers, and corporate offices. Nichibi Global ...
Breaking Medicine News(10 mins):Health News:CrossFit Gym in Vancouver WA Offers Spring Special 2Health News:SCI TV Covers Athlete Development with Duncan Fletcher 2Health News:SCI TV Covers Athlete Development with Duncan Fletcher 3Health News:Classic Denture Center in Portland Oregon is Offering March Discount 2Health News:Indosoft Proudly Announces Q-Suite 5.9 Call Center Software for Asterisk 2Health News:US Reclaimed Wood from Pioneer Millworks to be Featured at Architecture & Construction Materials Show in Tokyo. 2
... fire at Moscow drug rehabilitation clinic no. 17,faced one of the ... the last three decades //. 45 women were killed because of ... addicts below the age of 35.Some were HIV patients and few ... in fact warned a few months ago that the building ...
... Model developed with the systems biology approach may lead ... the researchers //at University of Montreal. ,Montreal ... Johns Hopkins University have made a major breakthrough in ... ,For the first time, using a systems ...
... Disorder suffer through a range of problems, from poor ... more than half of these children also have serious ... never learning to develop the social skills they need ... ,“Children with ADHD often are peer-rejected, and their difficulties ...
... a pre-kindergarten, families often have to forego considerations of ... school-home collaboration and provisions such as meals. // ... the FPG Child Development Institute at the University of ... of children in publicly funded pre-kindergarten (pre-K) programs define ...
... initiate a general discussion about the need for antidepressant ... to be thoroughly evaluated for depression than those who ... a new study in the December issue of Medical ... requests for antidepressants increased the likelihood that patients would ...
... agreement to support a $ 500 million research to further stem ... decision to legalise stem cell research, being only the second state ... million has already garnered enough support to gain the approval of ... M Cohen from D-Union who is one of the bills co-sponsors. ...
Cached Medicine News:Health News:Montreal Researchers And US Develop Model Of Key Immune-System Component 2Health News:Montreal Researchers And US Develop Model Of Key Immune-System Component 3Health News:Friendship Clinic: Psychologist Helps Children With ADHD Make Friends 2Health News:Friendship Clinic: Psychologist Helps Children With ADHD Make Friends 3Health News:Families Need More Than Quality Education from Pre-K Programs 2Health News:Patients' Requests for Antidepressants can Influence Physician Evaluation of Depression 2Health News:Patients' Requests for Antidepressants can Influence Physician Evaluation of Depression 3Health News:New Jersey Decides to Support $500 M Stem Cell Research 2
(Date:2/27/2015)... , Feb. 27, 2015 Pharmaceutical and biotech ... multiple products for the same indication. This can be ... want to prevent one of their brands from gaining ... According to recent research by benchmarking firm, Best Practices, ... independent brands rather than together as part of a ...
(Date:2/27/2015)... 2015  Pomerantz LLP is investigating claims on behalf ... "Company") (NASDAQ: VTAE ).  Such investors are ... rswilloughby@pomlaw.com or 888-476-6529, ext. 237. ... officers and/or directors have violated Sections 10(b) and 20(a) ... On February 27, 2015, the Company announced that ...
(Date:2/27/2015)... 2015  Following a bipartisan vote in the ... 284, the Medicare DMEPOS Competitive Bidding Improvement Act ... (AAHomecare) released a statement praising the Committee,s work ... legislation. "Today,s mark-up of the Competitive ... Means Committee is a critical step forward for ...
Breaking Medicine Technology:New Report Details How to Expand a Pharmaceutical Product Portfolio without Cannibalizing an Established Brand 2SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vitae Pharmaceuticals, Inc. - VTAE 2Bidding Fix Takes Major Step Forward After Bipartisan Vote of House Ways and Means Committee 2
... PharmaTech (Cayman) Inc. (NYSE: WX ), a ... with operations in China and the United States, today ... second quarter of 2011 after the New York Stock ... be Thursday morning, August 11, 2011 Shanghai time). The ...
... RAPIDS, Mich., July 19, 2011 ... rehabilitation and software services that benefit patients, healthcare ... to its multi-state group of outpatient clinics.  Agility ... the Company,s Michigan-based outpatient clinic presence to 23 ...
Cached Medicine Technology:WuXi PharmaTech Schedules Second-Quarter 2011 Earnings Release 2Agility Health Expands National Outpatient Clinic Group with New Michigan Facility 2
CDIs 2nd Stage Abdominoplasty Girdle - a feminine, easy pull-on version of the 8000 series...
... a smoother fit in the abdominal area ... padded continuous hook and eye closures extend ... extra strong, yet very thin zipper opens ... reinforced open crotch, gripper lace trim, and ...
For lipoplasty of trochanteric area, abdomen, thighs, hips, buttocks and flanks...
Below Knee Girdle, High Waist...
Medicine Products: