Navigation Links
Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
Date:8/19/2007

MARIETTA, Ga., Aug. 10 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today the receipt of an action letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for bifeprunox, an atypical antipsychotic that was reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The Agency stated that the drug was not approvable at this time.

The FDA stated in the letter that bifeprunox demonstrated effectiveness in the long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The Companies believe that bifeprunox offers distinct benefits for the long-term maintenance of patients with schizophrenia. The Companies will meet with the FDA to discuss the study design and to assess how this additional study combined with ongoing and planned studies can support a maintenance indication.

Although the FDA acknowledged that bifeprunox separated from placebo in two short-term studies in the acute setting, the Agency concluded that the efficacy data, when compared to reference drugs, were not sufficient for approval.

The Agency also requested further information regarding human metabolism of bifeprunox, and information regarding a complex case of a patient who died while participating in one of the trials.

"We believe that bifeprunox is a promising drug for the treatment of schizophrenia, and that there is a need for new treatment options to help people with schizophrenia manage their disease," says Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc. "
'/>"/>

SOURCE Solvay Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3

Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
2. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Mechanism of Action and Clinical Activity of Sulonex(TM) (sulodexide oral gelcap) at the Upcoming American Diabetes Association 67th Scientific Sessions in Chicago, Illinois
3. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data on Molecular Imaging Pharmaceutical for Prostate Cancer
4. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data at Society Of Nuclear Medicine 2007 Annual Meeting
5. CytRx Announces RNAi Delivery Nanoparticle Technology Exclusively Licensed to Subsidiary, RXi Pharmaceuticals, Described in Peer-Reviewed Journal
6. Progenics and Wyeth Announce Positive Results from Three-Month Clinical-Extension Study of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Advanced Illness
7. Wyeth Presents Phase 3 Data for Pristiq, an Investigational Non-Hormonal Therapy for Menopausal Hot Flashes and Night Sweats
8. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
9. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
10. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
11. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... CHAPEL HILL, N.C. , Aug. 28, 2015 ... critical market research projects can slow down the ... costs. It is, therefore, absolutely critical for biopharmaceutical ... the market research approval process for quicker and ... recent research by Best Practices, LLC, nearly three-quarters ...
(Date:8/28/2015)... 2015 Research and ... of the "Investigation Report on China,s Pranoprofen ... Originally discovered by Welfide (Mitsubishi Tanabe Pharma ... as an inflammatory drug, pranoprofen was later developed ... under the trade name of pranopulin for the ...
(Date:8/28/2015)... 2015 Research and Markets ... "Investigation Report on China,s Tobramycin Market, 2010-2019" ... traditional antibiotic whose eye drop and ointment are the ... infection or inflammation caused by eye infection. Currently, dozens ... able to produce tobramycin, among which the Top 5 ...
Breaking Medicine Technology:Expediting the Pharmaceutical Market Research Process for Faster Insights 2Investigation Report on China's Pranoprofen Market, 2010-2019 2Investigation Report on China's Tobramycin Market, 2015-2019 2
... 2010 Genomic Health, Inc. (Nasdaq: GHDX ) today ... 30, 2010. Total revenue increased to $46.3 million in ... third quarter of 2009.  Product revenue was $45.8 million in the ... $38.9 million in the third quarter of 2009. ...
... Nov. 8, 2010 PRNewswire-FirstCall/ -- Mesa Laboratories, Inc. (Nasdaq: ... has declared a regular quarterly dividend of $.12 per share ...  The dividend will be payable December 15, 2010, to shareholders ... public in 1984 Mesa Labs has maintained strong cash positions ...
Cached Medicine Technology:Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 2Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 3Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 4Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 5Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 6Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 7Genomic Health Announces Third Quarter 2010 Financial Results and Business Progress 8
(Date:8/29/2015)... ... August 29, 2015 , ... "I ... from Miller Place, N.Y. "I specialize in manual therapy, and my invention will ... can be used for additional muscle dysfunction throughout the body." , They developed ...
(Date:8/29/2015)... (PRWEB) , ... August 29, 2015 , ... ... mesothelioma develops, may extend and improve the lives of patients, according to a ... Click here to read the full article. , The authors of ...
(Date:8/29/2015)... ... August 29, 2015 , ... Brands like Toppik ... zero standard shipping costs. , “Before, a threshold of $49.00 was required to qualify ... and items qualify for free standard shipping for customers regardless of the item’s selling ...
(Date:8/29/2015)... ... , ... ProDrop Particles includes over 40 particle backdrops designed for use in ... that users can shrink and stretch in the Final Cut Pro X timeline. Choose ... brightness, scale, speed, range, and flare attributes with intuitive controls found in the top-right ...
(Date:8/29/2015)... York, NY (PRWEB) , ... August 29, 2015 ... ... successful results and include treating the localized area with stretching, soft tissue manipulation. ... a neutral pelvic position have shown through research to improve treatment outcomes. ...
Breaking Medicine News(10 mins):Health News:Inventors and InventHelp Clients Develops Tension Reliever (LGI-1951) 2Health News:Top Mesothelioma Researchers Highlight Targeted Therapies in New Report, According to Surviving Mesothelioma 2Health News:TheBeautyPlace.com Discounts Shipping on Select Brands 2Health News:FCPX Effects Developer, Pixel Film Studios, Releases ProDrop Particles. 2Health News:NEW APPROACH for Treatment of Recurrent Hamstring Strains and Hamstring Tendinosis is Available for the First Time in NYC 2Health News:NEW APPROACH for Treatment of Recurrent Hamstring Strains and Hamstring Tendinosis is Available for the First Time in NYC 3
... the Ganesh Shanker Vidyarthi Memorial (GSVM) Medical College have ... // in bringing medical knowledge and technology that would ... ,The two institutes have signed a memorandum ... increased collaboration on several fronts. ,The heads ...
... Association (AMA) says that the federal budget has poorly ... for not addressing problems like obesity //and indigenous health. ... develop world-first medical technologies to fight cancer and heart ... for the National Health and Medical Research Council by ...
... Japanese Encephalitis immunisation which was initially scheduled to take ... 15. //The Uttar Pradesh government is responsible for the ... dates. Japanese Encephalitis is the main reason for the ... Statistics show that in UP alone about 600-700 children ...
... of fungal infection in Bausch and Lomb lens wearers are ... association arrived at is that nearly 50% of those who ... solution, manufactured by Bausch and Lomb. ,Bausch & ... solution, feels that the cause of Fusarium keratitis infection is ...
... study, drinking tap water increases the risk of bladder cancer. ... if one drink too much of it may be a ... published in the April 15 issue of International Journal of ... based drinks each day increased the risk of bladder cancer ...
... Research (ICAR) has identified Indira Kankoda I (RMF 37), ... Chhattisgarh, Uttar Pradesh, Jharkhand, Orissa and Maharashtra. ... will be the first spine gourd variety identified for ... vegetable crop locally known as Meetha Karela, Khekhsa, Padora ...
Cached Medicine News:
... Lyphochek Fertility Control ... monitor the clinically significant ... most frequently assayed during ... Elevated hCG and hCG-Beta ...
Liquichek Spinal Fluid Control is a liquid, bilevel product designed to monitor the performance of automated and manual procedures for the analysis of proteins and other critical analytes assayed in ...
The Acceava hCG Combo test provides superior performance for the diagnosis of pregnancy with a simple procedure that provides easy to read black on white results in 3 minutes for urine or 5 minutes f...
... Nucleic Sample Preparation Platform provides flexible, automated ... platform can prepare up to 96 patient ... and one half-hours, and performs onboard quantitation ... 30 minutes each. Based on Beckman ...
Medicine Products: