Labopharm Initiates Phase III Clinical Study for Once-Daily Formulation of Trazodone



    - Once-Daily Trazodone Formulation Has Potential to Offer Unique Approach
    to Treating Major Unipolar Depressive Disorder -

    LAVAL, QC, June 7 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ:   DDSS) today
announced that it has begun enrolling patients in its North American Phase III
clinical trial for its once-daily formulation of the antidepressant trazodone
(study 04ACL3-001).
    "Depression is one of the most prevalent central nervous system
disorders, affecting at least 121 million people globally, and trazodone is
widely used in its treatment with more than 14 million prescriptions written
in the U.S. alone in 2006," said James R. Howard-Tripp, President and Chief
Executive Officer, Labopharm Inc. "Insomnia and agitation may be associated
with depression. In addition to its anti-depressive effects, trazodone has
sedative effects that can improve sleep. Our once-daily formulation has been
specifically designed to take advantage of trazodone's unique pharmacological
properties, in addition to offering the benefits of once-daily administration
and potentially fewer side effects generally associated with peak
concentrations of drugs. As a once-a-day product, we believe our formulation
of trazodone has the potential to provide a novel approach to treating major
unipolar depression."
    Study 04ACL3-001 is a randomized, double-blind study which will compare
the efficacy and safety of Labopharm's once-daily formulation of trazodone to
placebo in patients with major unipolar depressive disorder. The study, which
has a treatment period of approximately two months, is being conducted at more
than 35 centers across the U.S. and Canada and is expected to include more
than 350 subjects.
    Based on discussions with U.S. Food and Drug Administration (FDA),
Labopharm expects to submit a New Drug Application (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. Under this Section of the Act,
one positive Phase III study is required for the formulation to be approved by
the FDA.
    Pilot pharmacokinetic trials have demonstrated that Labopharm's
once-daily formulation of trazodone has controlled-release properties over a
24-hour period.

    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 receptors of the 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.

    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. 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 outcomes of clinical trials, the
regulatory process and the commercialization of the Company's products
thereafter, 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, 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: Eric
Bouchard, Tel: (514) 208-5939, ebouchard@equicomgroup.com

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