- Company to Also Present Clinical Data at
Upcoming Scientific Meeting -
LAVAL, QC, May 19 /CNW/ - 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
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
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
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.
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,