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

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:
(Date:8/30/2014)... August 30, 2014 Market Research ... 2009-2019 is a professional and in-depth market survey ... report firstly reviews the basic information of Cell ... The report then explores global and China’s top ... capacity, Production value, and market share etc. The ...
(Date:8/30/2014)... HealthDay Reporter FRIDAY, Aug. ... operated on for broken bones or other orthopedic trauma shops ... Less-educated patients and patients who had used narcotic ... shoppers," said study lead author Dr. Brent Morris, a shoulder ... study suggests that doctors aren,t talking to one another about ...
(Date:8/30/2014)... Market Research Report on Global and ... and in-depth market survey on Global and Chinese ... basic information of Lab Oven including its classification, ... global and China’s top manufacturers of Lab Oven ... market share etc. , The report further analyzes ...
(Date:8/30/2014)... "I had a handicapped friend who could not ... inventor from Wetumpka, Ala. "In order to help her be ... I came up with a way for her to use ... for the patent-pending Deezers to allow crutches to be used ... crutches, walkers, or canes at the beach. The device reduces ...
(Date:8/30/2014)... 30, 2014 Top10BestSEOHosting.com is a ... have announced that HostGator.com http://secure.hostgator.com/~affiliat/cgi-bin/affiliates/clickthru.cgi?id=seohosts is ... market. Also, they has announced that Bluehost and ... , Hostgator, one of the Top 10 Web ... cheap Windows hosting, and it offers rich features ...
Breaking Medicine News(10 mins):Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 2Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 3Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 4Health News:'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds 2Health News:'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds 3Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 2Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 3Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 4Health News:Top10BestSEOHosting.com: HostGator.com Is The Best Windows Hosting Supplier 2
... Anatomist Dr. Gunther von Hagens - creator of the ... his name - issued a clarification to French media and ... cadaver display announced in Paris, with his own BODY ... have been an anatomist for more than thirty five years, ...
... 2009, Cambridge, UK Cell lifespan is limited ... the number of times a cell may be copied. ... Mechanisms (DMM), dmm.biologists.org , describes how telomere ... cancer risk and pigmentation. , Researchers from Spain investigated ...
... The show will be about an intervention and the ... ago only 3% of compulsive gamblers were women, today ... (located in Hanover, VA) specializes in treating compulsive gambling, ... only such licensed treatment centers in the US), encourages ...
... identified a small family of lab-made proteins that neutralize ... H5N1 avian virus, the 1918 pandemic influenza virus and ... infection-fighting proteins derived from the same cell lineage, also ... H5N1 and other influenza A viruses. Because large quantities ...
... PAF Selected as Charitable Partner for National Initiative as ... and Fundraiser NEWPORT NEWS, Va., Feb. 22 The ... that provides patient services to tens of thousands of ... to care because of financial or insurance denials - ...
... Feb. 22 Statement of Eliseo Medina and David Regan, ... Daily Labor Report that the National Labor Relations Board has ... of UHW to weaken their former local. The NLRB ... Practices after learning that the ousted leaders of UHW had ...
Cached Medicine News:Health News:Anatomist Dr. Gunther von Hagens, Pioneer of Anatomical Exhibitions Not Affiliated With Copycat Display in Paris 2Health News:The first Intervention About Women Compulsive Gamblers Airs on A&E February 23, 2009 at 9 PM: Williamsville Wellness will be Featured 2Health News:Scientists identify lab-made proteins that neutralize multiple strains of seasonal and pandemic flu 2Health News:Scientists identify lab-made proteins that neutralize multiple strains of seasonal and pandemic flu 3Health News:Scientists identify lab-made proteins that neutralize multiple strains of seasonal and pandemic flu 4Health News:Patient Advocate Foundation Partners with Breakaway from Cancer, Raising Awareness and Funds for Free Services Available to Cancer Patients 2Health News:Patient Advocate Foundation Partners with Breakaway from Cancer, Raising Awareness and Funds for Free Services Available to Cancer Patients 3
(Date:8/29/2014)... Research and Markets has announced ... Forecast of Pharmaceutical Equipment Market in China, 2014-2018" ... Development Trend Forecast of Pharmaceutical Equipment Market in ... China,s pharmaceutical equipment industry in the aspects ... and business performance of domestic major enterprises, as well ...
(Date:8/29/2014)... Corporation , a neurodiagnostics medical device company based in ... Forcht Dagi , MD, DmedSc, MPH, MBA, FACS, FRCSEd  was ... " Teo Forcht Dagi is an experienced leader with ... said Remis Bistras , President and CEO of Vittamed. ... entrepreneurial expertise to our Board." Dr. Dagi is ...
(Date:8/29/2014)... Diseases largely eradicated in the ... Measles was declared eliminated in 2000, yet the CDC ... 15—the highest incidence in 20 years. In July, ... cough a problem of "epidemic proportions." ... from these preventable diseases—in part because some parents (more ...
Breaking Medicine Technology:Research and Development Trend Forecast of Pharmaceutical Equipment Market in China, 2014-2018 2Vittamed Adds Prominent Neurosurgeon and Venture Capitalist T. Forcht Dagi to Board of Directors 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3
... The TOPCON ALE-3600 ... Systems assure perfectly fit ... accurately and with the ... operation. These lens edgers ...
...
Inquire...
... The TOPCON OM-4 Ophthalmometer ... compactly designed and easy ... providing precise objective measurements ... of curvature plus accurate ...
Medicine Products: