Results of phase III study on Labopharm's novel antidepressant published in Psychiatry...

Results of phase III study on Labopharm's novel antidepressant published in
Psychiatry (Edgemont) Journal

- Company to Also Present Clinical Data at
Upcoming Scientific Meeting -

LAVAL, QC, May 19 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ:
DDSS) today announced the publication of Extended Release Trazodone in Major
Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Study in
the May 2009 issue of the journal Psychiatry (Edgemont) (Volume 6, Number 5)
(www.psychiatrymmc.com). The results of this Phase III clinical trial (study
04ACL3-001), which were originally reported by the Company in February 2008,
demonstrate clear benefits for Labopharm's novel antidepressant.
More than 120 million people around the world suffer from depression.
Treatment is often challenging because response to antidepressant drug therapy
can vary significantly. Clinically depressed patients are typically treated
with two different types of drug therapy: selective serotonin reuptake
inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).
However, some 40 to 50% of patients being treated for depression stop taking
these antidepressant drugs within the first 12 months of treatment. Frequently
cited reasons for discontinuing therapy include suboptimal efficacy on
depression symptoms, exacerbation of sleep disturbance, increased agitation,
slow onset of action, sexual dysfunction and weight gain.
Labopharm's novel formulation of the antidepressant trazodone is designed to
optimize the efficacy of trazodone, and address the major challenges in
treating depression.

Summary of Results of Labopharm's Phase III Clinical Trial on Trazodone

Labopharm's multi-center phase III clinical trial compared the efficacy and
safety of Labopharm's novel trazodone formulation to placebo in patients with
major unipolar depressive disorder (MDD).
The results of primary efficacy end point analyses demonstrated consistent
statistical superiority of Labopharm's trazodone formulation over placebo.
Moreover, statistically significant improvements were demonstrated on several
secondary efficacy end points, including Hamilton Rating Scale for Depression
(HAMD-17) responders, Montgomery-Asberg Depression Rating Scale (MADRS) score,
and quality of sleep.
The authors emphasize the clinical importance of targeting sleep improvement
in patients with MDD, which is reported in more than 90% of cases. Patients
receiving Labopharm's trazodone formulation 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".
Agitation is a common symptom of MDD and patients taking antidepressants often
experience an exacerbation of this symptom. In the study, those administered
Labopharm's trazodone formulation showed no increase in agitation.
The results of the study demonstrate Labopharm's once-daily trazodone may have
a early onset of action. The overall antidepressant efficacy of Labopharm's
trazodone formulation was accompanied by improvements early in the study,
including an early improvement in HAMD-17 scores, which suggest that patients
may see clinical benefit within the first 2 weeks of treatment, and a
significantly greater number of HAMD-17 responders than placebo by the end of
titration.
Adverse events of particular concern in the treatment of MDD are those related
to weight gain and sexual dysfunction, as they are among the most prevalent
reasons for discontinuation of antidepressant therapy. In the study, there
were no significant changes in body weight in either those administered
Labopharm's trazodone formulation or those administered placebo and there was
a low incidence of sexual dysfunction in both groups.
The authors conclude that Labopharm's trazodone formulation, at the
recommended daily dosage of 300 mg, appeared to be an appropriate monotherapy
for patients with MDD.

Poster of Phase III Study to Appear at Scientific Meeting in Florida

Labopharm will present a poster discussing the results of the Phase III
clinical trial of its novel trazodone formulation at the 49th Meeting of the
New Clinical Drug Evaluation Unit (NCDEU) of the National Institute of Mental
Health to be held from June 29 to July 2, 2009. The poster, entitled
Once-Daily Trazodone in Major Depressive Disorder: Double-Blind,
Placebo-Controlled Study, concludes Labopharm's trazodone formulation is an
effective and well-tolerated treatment for MDD patients, which improves
quality of sleep.

About Labopharm's Novel Antidepressant

Labopharm's novel trazodone formulation is currently under regulatory review
in the United States by the Food and Drug Administration (FDA). The action
date under the Prescription Drug User Fee Act (PDUFA) is July 18, 2009.

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,
the United Kingdom, France, Spain, Italy, Germany and Australia, among others.
The company's 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.

SOURCE Labopharm Inc.

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, jhogan@equicomgroup.com; French: Joe
Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com