Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone



    - Study Achieves Primary Efficacy Endpoint and Demonstrates Improved
    Quality of Sleep -

    LAVAL, QC, Feb. 8 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ:   DDSS) today
announced that its recently completed North American Phase III clinical trial
for its once-daily formulation of the antidepressant trazodone (study
04ACL3-001) achieved statistical significance for the primary efficacy
endpoint (p value of 0.0183). The study also demonstrated significantly
improved patient sleep patterns in favour of trazodone. Labopharm plans to
file a New Drug Application (NDA) for its once-daily formulation of trazodone
with the U.S. Food and Drug Administration later this year.
    "The positive results of this study not only demonstrate the efficacy and
safety of our once-daily formulation, but also the ability of our formulation
to significantly improve the overall quality of sleep - there was
significantly less awakening at night," said James R. Howard-Tripp, President
and Chief Executive Officer, Labopharm Inc. "It is recognized that a major
challenge in treating depression is having patients comply with taking their
medication due to slow onset of action and exacerbation of sleep disturbance
and agitation. As a result, a once-daily depression treatment that also
reduces agitation and improves quality of sleep, thus reducing the need for
add-on therapies, should be well positioned in the antidepressant marketplace.
We believe that our once-daily trazodone formulation is such a treatment."

    Results of the Study

    Study 04ACL3-001 is a randomized, double-blind, two-arm, multi-centre
study comparing the efficacy and safety of Labopharm's once-daily trazodone
formulation to placebo, in patients with major unipolar depressive disorder,
over an eight-week period. In the study, 412 patients were randomized to
treatment with Labopharm's once-daily trazodone, or placebo. Within the
initial two-week titration period, patients were titrated every three to four
days to an optimal dose (maximum dose of 375 mg/day). Patients were then
maintained at the optimal dose for the remainder of the study. The study was
conducted at 40 centers across the U.S. and Canada.
    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 once-daily trazodone group versus the placebo
group. Statistical significance was achieved for the primary endpoint
(p value of 0.0183) and under additional methods of analysis as specified in
the Statistical Analysis Plan (SAP). The overall drop out rate in the study
was 25.5%. The drop out rate was 21% in the placebo group and 30.2% in the
once-daily trazodone group. In the once-daily trazodone group, 4% 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.
    Based on discussions with the FDA, Labopharm expects to submit an 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. The Agency advised
the Company that one positive Phase III study is required for the formulation
to be approved.

    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.

    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 price of the Company's shares, the uncertainties related to 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, 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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