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 tolerated adverse event profile, a very low rate of sexual dysfunction and no weight gain compared to placebo.

MDD is one of the most prevalent central nervous system disorders, affecting more than 120 million people worldwide. In 2007, the global market for antidepressants and related psychiatric drugs was US$19 billion, of which US$12 billion was accounted for by the U.S.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.


'/>"/>
SOURCE Labopharm Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:2/10/2016)... ... February 10, 2016 , ... ... unveiling its revolutionary new 2.0 version at the International Roofing Expo in Orlando, ... power of the world's most advanced weather technology in the hands of consumers, ...
(Date:2/10/2016)... ... February 10, 2016 , ... InDemand Interpreting , a ... partnered with Heart City Health Center to improve access to language ... City Health Center has provided the Elkhart community with access to high quality, ...
(Date:2/10/2016)... NY (PRWEB) , ... February 10, 2016 , ... ... compliance tracking solution, The Guard, to associations of medical professionals throughout the country. ... compliance, including security risk assessments, policies and procedures, employee training, regulatory updates, and ...
(Date:2/10/2016)... ... , ... Emergency rooms provide emergency care to stabilize critical health issues, but ... dental emergencies at risk of losing a tooth or their smiles. Dr. Marine Martirosyan, ... dental emergencies include:, , Avulsed or knocked-out teeth , ...
(Date:2/10/2016)... CA (PRWEB) , ... February 10, 2016 , ... ... Valley , announces that his office is now offering a variety of comprehensive ... enhancement, chin enhancement, eyebrow lift, facial volume restoration, lip enhancement and nasal reshaping. ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Calif., Feb. 10, 2016   Genomic Health, Inc. (Nasdaq: ... the quarter and year ended December 31, 2015. ... fourth quarter of 2015, compared with $69.1 million in the fourth ... currency basis, revenue increased 9 percent compared with the same period ... U.S. revenue was $63.9 million in the fourth quarter of ...
(Date:2/10/2016)... 2016 Mylan N.V. (NASDAQ, TASE: MYL) today ... ended December 31, 2015. --> ... total revenues of $9.45 billion, up 28% on a ... revenues of $9.43 billion. Excluding the impact of the ... branded generics business (the "EPD Business"), full year adjusted ...
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
Breaking Medicine Technology: