Navigation Links
Labopharm's NDA for Novel Trazodone Formulation accepted for review by FDA
Date:11/24/2008

- Action Date is July 18, 2009 -

LAVAL, QC, Nov. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA). The action date under the Prescription Drug User Fee Act (PDUFA) is July 18, 2009.

Labopharm's NDA for its novel trazodone formulation is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. The Agency advised the Company that one positive Phase III study is required for the formulation to be approved.

About Labopharm's Novel Trazodone Formulation and the Market for Antidepressants

One-half of patients being treated with antidepressants discontinue therapy within a year for reasons related to efficacy and/or tolerability, including delayed onset of therapeutic response, insomnia or sleep disturbance, agitation, exacerbation of anxiety, sexual dysfunction, weight gain and somnolence. Labopharm has developed a novel once-daily formulation of 150 mg and 300 mg of trazodone hydrochloride, a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder (MDD) to address patient needs in the current depression landscape, providing an effective and convenient treatment option. In a Phase III placebo controlled study of patients with MDD, Labopharm's novel trazodone formulation demonstrated antidepressant efficacy, including rapid onset of therapeutic response, improved overall quality of sleep, a well t
'/>"/>

SOURCE Labopharm Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine news :

1. E6 Ventures Invests in Novel Coatings Developer, Diamond Hard Surfaces Ltd
2. Novel imaging technique reveals brain abnormalities that may play key role in ADHD
3. Future Looks Bright For Non-Invasive Diagnosis Of Skin Cancer; Study Shows Novel Light Device Detects Cancerous Lesions From Normal Tissue
4. Novel IBS treatment developed at UB garners $8.5 million for seven-year clinical trial
5. Novel 4-drug combination proves safe for lung cancer treatment
6. Porter Novelli Named Agency of Record for Pharmavite(R) LLC
7. Completely novel action of insulin unveiled
8. Yo Mujer: Woman Escapes from Abusive Marriage in New Spanish-Language Novel
9. Moores UCSD Cancer Center studying novel leukemia vaccine for high-risk patients
10. Preliminary Clinical Data Presented at the 20th EORTC-NCI-ACR Symposium on Molecular Targets and Cancer Therapeutics Demonstrate Superior Profile of S*BIOs Novel Anti-Cancer Drug SB939
11. Novel Solid-State Laser Design Based on Synthetic Diamond From Element Six Opens up New Applications
Post Your Comments:
*Name:
*Comment:
*Email:
Breaking Medicine Technology:Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 2Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 3Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 4Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 5Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 6Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 7Reportlinker Adds Radiation Therapy Equipment - A Global Market Review 8Remote Technologies Improve Patient Care, Viable Alternative to Intensivist Shortage 2Remote Technologies Improve Patient Care, Viable Alternative to Intensivist Shortage 3Veran Medical Receives FDA Clearance to Market Electromagnetic Navigated Bronchoscopy Product: The SPiN Drive(TM) System 2Study Shows GSKs Novel Diabetes Treatment SYNCRIA 28R 29 28albiglutide 29 Improves Glucose Control and Reduces Weight 4549 1Study Shows GSKs Novel Diabetes Treatment SYNCRIA 28R 29 28albiglutide 29 Improves Glucose Control and Reduces Weight 4549 2Study Shows GSKs Novel Diabetes Treatment SYNCRIA 28R 29 28albiglutide 29 Improves Glucose Control and Reduces Weight 4549 3Orange County Laser Surgeon Nissan Pilest Tapped as Keynote Speaker at Fraxel 26amp 3B Thermage User Forum Held at Beckman Laser Institute 12498 1Orange County Laser Surgeon Nissan Pilest Tapped as Keynote Speaker at Fraxel 26amp 3B Thermage User Forum Held at Beckman Laser Institute 12498 2Orange County Laser Surgeon Nissan Pilest Tapped as Keynote Speaker at Fraxel 26amp 3B Thermage User Forum Held at Beckman Laser Institute 12498 32009 Houston Juneteenth Multicultural Health Festival Becomes Largest Health Event in Texas 3A Festival Moves Indoors to the Cool George R Brown 48107 12009 Houston Juneteenth Multicultural Health Festival Becomes Largest Health Event in Texas 3A Festival Moves Indoors to the Cool George R Brown 48107 2