Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation

    LAVAL, QC, April 2 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ:   DDSS) today
announced the results of its recently completed North American Phase III
clinical trial for its twice-daily formulation of tramadol and acetaminophen
(study 06CCL3-001).
    Study 06CCL3-001 was a multi-centre, randomized, double-blind,
parallel-arm study that compared the efficacy and safety of Labopharm's
twice-daily tramadol-acetaminophen formulation to placebo in the treatment of
moderate to severe acute low back pain. A total of 277 patients were included
in the study. Thirteen percent (13%) of patients in the active treatment group
discontinued early (12% due to adverse events) and 5% of patients in the
placebo group discontinued early (2% due to adverse events).
    Results of the efficacy measures in the study demonstrated a
statistically significant difference from placebo in some cases but not in
others. An analysis of covariance demonstrated a statistically significant
difference from placebo on the Sum of Pain Intensity Differences (SPID) over
50 hours using LOCF (last observation carried-forward) as the imputation
method, however, the results were not statistically significant using
LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A
non-parametric analysis, however, demonstrated statistical significance using
both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on
the Total Pain Relief (TOTPAR) score was also statistically significant using
both LOCF and LOCF/BOCF imputation methods and the patients' global impression
of the effectiveness of the study medication was statistically different from
placebo. Statistical significance reflects a p-value of less than 0.05 in each
of the analyses.
    Regulatory authorities throughout the world have different requirements
for the analysis and demonstration of efficacy in clinical trials. Labopharm
believes that it is likely that the results of this trial are insufficient to
support the acceptance of a New Drug Application (NDA) by the Food and Drug
Administration (FDA) in the United States. The Company intends to discuss the
matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology
Products (DAARP) to determine the path forward. The results of this study are
however statistically significant under analyses that the Company believes may
be accepted for the evaluation of analgesics in Europe, Canada and other
jurisdictions. Accordingly, the Company intends to meet with the regulatory
authorities for these jurisdictions at the earliest available opportunity in
pursuit of regulatory approval. Should the authorities be in agreement, the
Company expects that it would submit a regulatory application in those
    The Company will provide additional information following discussions
with the various regulatory authorities.
    The results of the study have no bearing on the upcoming launch of the
Company's once-daily tramadol product in the United States.

    About Tramadol-Acetaminophen Combination Products

    Tramadol-acetaminophen products leverage the unique but complementary
modes of action of each of the active ingredients to provide the analgesic
strength of a mild opioid (tramadol) and the rapid pain relief of
acetaminophen. Tramadol-acetaminophen combination products were first launched
in 2001 in the United States and in 2003 in other major markets and are
indicated for the short-term (five days or less) management of acute pain in
the U.S. and the symptomatic treatment of moderate to severe pain in the rest
of the world.

    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 and its 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

    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, 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,; French: Joe Racanelli, Tel: (514) 844-7997,

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