Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug



    LAVAL, QC, Sept. 25 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ:   DDSS) today
announced that it has completed patient enrolment in its North American Phase
III clinical trial for its once-daily formulation of the antidepressant
trazodone (study 04ACL3-001). More than 400 patients have been enrolled in
this study and the final patient is scheduled for randomization at the end of
this week.
    "Our proprietary Contramid(R) controlled-release technology applied to
trazodone has allowed us to develop a novel approach to treating major
unipolar depression that addresses the related conditions of insomnia and
agitation while providing the benefit of once-daily administration," said
James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.
"We are excited about the prospects for this novel approach to treating
depression and are pleased to have completed enrolment for our Phase III study
ahead of schedule. We now expect to have results from the study at the
beginning of the second quarter of 2008."
    Trazodone is widely used in the treatment of depression due to its
efficacy, as well as its side effect profile as a member of the serotonin
agonist and serotonin reuptake inhibitor (SARI) class of antidepressants. The
use of existing formulations of trazodone, however, is limited by the need for
multiple-times daily dosing and trazodone's sedative effect on some patients.
Depression is often accompanied by insomnia and agitation. In developing a
Contramid-based once-daily formulation of trazodone with a dual matrix
delivery system allowing both rapid and sustained drug release, Labopharm is
taking advantage of trazodone's sedative effect such that its formulation,
when taken prior to going to bed, may address insomnia and agitation, two
conditions that are often related to depression.
    Study 04ACL3-001 is a randomized, double-blind study which compares 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.
    Pharmacokinetic trials have demonstrated that Labopharm's once-daily
formulation of trazodone has controlled-release properties over a 24-hour
period.
    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.

    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. Trazodone is widely
used in its treatment with more than 14 million prescriptions written in the
U.S. alone in 2006.

    About Labopharm's Once-Daily Formulation of Trazodone

    Insomnia and agitation may be associated with depression. In addition to
its anti-depressive effects, trazodone has some sedative effects that can
improve sleep. Labopharm's 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.

    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 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 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.





For further information:

For further information: At Labopharm: (English or French), 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) 844-7997,
ebouchard@equicomgroup.com

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