LAVAL, QC, Aug. 5 /CNW/ - 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
"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
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
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
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.
For further information:
For further information: At Labopharm: Mark D'Souza, Senior
Vice-President and Chief Financial Officer, Tel: (450) 686-0207; At The
Equicom Group: Jason Hogan, Media and Investor Relations, Tel: (416) 815-0700,
firstname.lastname@example.org; French: Joe Racanelli, Tel: (514) 844-7997,