Navigation Links
Labopharm files New Drug Submission with Health Canada for novel antidepressant
Date:8/5/2009

LAVAL, QC, Aug. 5 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone.

"We are pleased to file our New Drug Submission to Health Canada," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe the $800 million-plus Canadian market for antidepressants represents a significant opportunity for our trazodone formulation and we are currently in discussions with potential partners to support the commercialization of our product in Canada."

Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients.

The eight-week randomized, double-blind, two-arm, multi-centre Phase III study in patients with major unipolar depressive disorder demonstrated the efficacy of Labopharm's formulation as a treatment for depression, as well as its positive effect on quality of sleep. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.012). The majority of the secondary efficacy end points, including the HAMD-17 depressed mood item, the Clinical Global Impressions Severity (CGI-S) scale, the Montgomery Asberg Depression Rating Scale (MADRS) total score and a Responder's Analysis showed statistical significance in favor of the group administered Labopharm's trazodone. In addition, patients on Labopharm's trazodone demonstrated significant improvements versus placebo in all three quality of sleep end points, with an improvement by the first week of therapy in "overall quality of sleep" and "awakening during the night". The incidence of agitation, weight gain and sexual dysfunction in patients administered Labopharm's trazodone was no different from placebo. The overall drop out rate in the study was 25 percent. The drop out rate was 21 percent in the placebo group and 30 percent in the trazodone group. In the trazodone group, four percent of patients discontinued treatment due to somnolence or sedation. The drop out rate observed in this study is comparable to drop out rates in typical depression studies. The results of this study are found in the May 2009 issue of Psychiatry (Edgemont) (Volume 6, Number 5) (www.psychiatrymmc.com).

Major depressive disorder (MDD) is a common mental illness often characterized by a combination of symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Approximately 8% of adults will experience major depression at some time in their lives.

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 now available in 17 countries around the world, including the U.S., Canada, major European markets and Australia. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. 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©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Quark Pharmaceuticals Files Patent Application Covering Novel Chemical Modifications to its RNAi Molecules
2. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
3. AngioGenex Files Patent on First Small Molecule Id-Inhibitors for the Treatment of Cancer
4. Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
5. Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
6. Further Clinical Testing of BZL101 in Advanced Breast Cancer Demonstrates Favorable Efficacy and Toxicity Profiles
7. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
8. FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
9. Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer
10. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
11. deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimers and Other Cognitive Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Feb. 4, 2016  SciClone Pharmaceuticals, Inc. (NASDAQ: ... has entered into a settlement agreement with the ... resolving the SEC,s investigation into possible violations of ... terms of the settlement agreement, SciClone has agreed ... disgorgement, pre-judgment interest and a penalty.  This payment ...
(Date:2/4/2016)... -- Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD) ... Chronic Obstructive Pulmonary Disease (COPD) is a ... airways and lungs. Persistent breathing difficulties and repeated ... of the leading causes of morbidity and the ... is linked to cumulative exposure to risk factors, ...
(Date:2/4/2016)... ALBANY, N.Y. , Feb. 4, 2016  AMRI (NASDAQ: ... Vice President of Pfizer Inc. and President of Pfizer Global ... effective as of February 4, 2016. In addition, the Company ... member of the audit committee since 2010, has retired from ... time and attention to his other business ventures.  ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV show, ... much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream on ... week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors - ...
(Date:2/5/2016)... New York, New York (PRWEB) , ... February 05, 2016 , ... ... your life? The answer may be at the tips of your toes. Foot massage, ... benefits as well as pure comfort and relaxation. The American Board of Multiple ...
(Date:2/5/2016)... ... February 05, 2016 , ... In the fourth quarter of ... at the La Valencia Hotel in San Diego, California to discuss changes in ... year’s most outstanding franchise, walking away with the coveted David Wright Award of ...
(Date:2/5/2016)... ... 2016 , ... Pivot Point Consulting, a leading national Healthcare ... Services for HIT Implementation Support & Staffing report with an outstanding score of ... healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. , ...
(Date:2/5/2016)... ... , ... Colorize is a web theme package created exclusively for ... Colorize's dynamic moving camera. Colorize is perfect for personal and web related videos and ... 1 to 5 focus points per scene, stage floor scene presets that are great ...
Breaking Medicine News(10 mins):