Navigation Links
Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone

- Study Achieves Primary Efficacy Endpoint and Demonstrates Improved

Quality of Sleep -

LAVAL, QC, Feb. 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that its recently completed North American Phase III clinical trial for its once-daily formulation of the antidepressant trazodone (study 04ACL3-001) achieved statistical significance for the primary efficacy endpoint (p value of 0.0183). The study also demonstrated significantly improved patient sleep patterns in favour of trazodone. Labopharm plans to file a New Drug Application (NDA) for its once-daily formulation of trazodone with the U.S. Food and Drug Administration later this year.

"The positive results of this study not only demonstrate the efficacy and safety of our once-daily formulation, but also the ability of our formulation to significantly improve the overall quality of sleep - there was significantly less awakening at night," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "It is recognized that a major challenge in treating depression is having patients comply with taking their medication due to slow onset of action and exacerbation of sleep disturbance and agitation. As a result, a once-daily depression treatment that also reduces agitation and improves quality of sleep, thus reducing the need for add-on therapies, should be well positioned in the antidepressant marketplace. We believe that our once-daily trazodone formulation is such a treatment."

Results of the Study

Study 04ACL3-001 is a randomized, double-blind, two-arm, multi-centre study comparing the efficacy and safety of Labopharm's once-daily trazodone formulation to placebo, in patients with major unipolar depressive disorder, over an eight-week period. In the study, 412 patients were randomized to treatment with Labopharm's once-daily trazodone, or placebo. Within the initial two-week titration period, patients were titrated every three to four days to an optimal dose (maximum dose of 375 mg/day). Patients were then maintained at the optimal dose for the remainder of the study. The study was conducted at 40 centers across the U.S. and Canada.

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 once-daily trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.0183) and under additional methods of analysis as specified in the Statistical Analysis Plan (SAP). The overall drop out rate in the study was 25.5%. The drop out rate was 21% in the placebo group and 30.2% in the once-daily trazodone group. In the once-daily trazodone group, 4% 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.

Based on discussions with the FDA, Labopharm expects to submit an NDA for its once-daily formulation of trazodone under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act, which typically applies to reformulations of drugs that are already approved and being marketed, allowing the Company to leverage existing efficacy and safety data on trazodone. The Agency advised the Company that one positive Phase III study is required for the formulation to be approved.

About Trazodone

Trazodone is an atypical anti-depressant that acts as a dual serotonin agonist and serotonin reuptake inhibitor (SARI). Trazodone appears to increase serotonin activity via three mechanisms: the activation of neuronal serotonin receptors; the inhibition at the neuronal serotonin feedback system which regulates the action of serotonin; and the inhibition of the re-uptake of serotonin. Trazodone also helps to treat depression by improving sleep as a result of sedative effects caused by activation of histamine receptors and initiation and restoration of deep sleep cycles as a result of serotonin receptor activation. This may be of clinical benefit in depressed patients who have agitation, insomnia or poor sleep quality associated with their depression. Depression is one of the most prevalent central nervous system disorders, affecting at least 121 million people globally.

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. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become a fully integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit

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 price of the Company's shares, the uncertainties related to the regulatory process for drug approval and the commercialization of the Company's products, 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. Canadian Marketing and Sales Effort for Labopharms Once-Daily Tramadol Product to Expand Significantly
2. Labopharm enters into licensing and distribution agreement for once-daily tramadol in Australia with iNova
3. Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
4. Labopharm Reports Results for Third Quarter Fiscal 2007
5. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
6. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
7. Labopharm appeals FDAs decision on once-daily tramadol
8. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
9. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
10. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
11. CardioDynamics Reports Fourth Quarter and Fiscal 2007 Results with 10% Revenue Growth in 2007
Post Your Comments:
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance ... and the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, ... Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood cells, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
(Date:6/23/2016)... June 23, 2016  MedSource announced today that ... e-clinical software solution of choice.  This latest decision ... value to their clients by offering a state-of-the-art ... relationship establishes nowEDC as the EDC platform of ... full-service clients.  "nowEDC has long been a preferred ...
Breaking Medicine Technology: