- Article Discussing Analgesic Efficacy of Labopharm's Once-Daily
Tramadol Published in Journal of Pain and Symptom Management -
- Company Secures Marketing Partner for Once-Daily Tramadol in Israel -
LAVAL, QC, Sept. 14 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that it will present a poster discussing the ability of its
once-daily formulation of tramadol to rapidly attain therapeutic plasma levels
and provide quick onset of clinically significant analgesia at the XXIV Annual
Congress of the European Society of Regional Anaesthesia and Pain Therapy to
be held September 12 to 15, 2007 in Valencia, Spain.
The poster presents the results of a multi-centre, open-label,
single-dose study examining Labopharm's once-daily formulation of tramadol
(200 mg tablets) in patients with moderate to severe acute low back pain. The
results of the study suggest that Labopharm's once-daily tramadol formulation
provided therapeutic plasma concentrations and onset of analgesic effect
within one hour, similar to that cited in the literature for the
immediate-release tramadol product. The median duration to onset of pain
relief was 45 minutes, at which time 78% of patients had moderate to complete
pain relief (43% having a lot to complete pain relief and 35% having moderate
"The rapid onset of analgesia suggested by the results of this study of
our once-daily tramadol combined with the sustained 24-hour analgesia as
demonstrated by our formulation in previous studies should provide a
clinically significant benefit to patients," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc.
The poster will be available on Labopharm's web site (www.labopharm.com)
on Monday, September 17, 2007, following conclusion of the Congress.
Labopharm also announced today that an article discussing the positive
outcome of clinical study MDT3-005, "A Comparison of the Analgesic Efficacy of
Tramadol Contramid OAD Versus Placebo in Patients with Pain Due to
Osteoarthritis" has been published in the September 2007 edition of the
Journal of Pain and Symptom Management (Vol. 34, No. 3, Pages 328-338).
The article discusses the results of clinical trial MDT3-005, a
multi-center, randomized, double-blind, parallel study designed to assess the
analgesic efficacy and safety of Labopharm's once-daily formulation of
tramadol compared to placebo in patients with osteoarthritis of the knee. An
absolute mean reduction of 3.0 +/- 2.1 on an 11-point Pain Intensity Numerical
Rating Scale (PI-NRS) was noted in the Labopharm once-daily tramadol treatment
group. The difference between active and placebo groups was statistically
significant (P less than 0.001). The responder analysis demonstrated that a
significantly greater percentage of patients in the active treatment arm
achieved clinical pain relief (a reduction greater than or equal to 2 points
on the PI-NRS score) by the end of the study (P equals 0.035). A significantly
greater percentage of respondents in the Labopharm once-daily tramadol group
indicated improvement on both the Patient and Physician Global Impressions of
Change (P equals 0.0002). Both the 200 mg and 300 mg doses contributed to the
overall superiority of Labopharm's once-daily tramadol. The most frequent
adverse events were consistent with the known side effects of tramadol and
were generally mild to moderate in intensity. The article concludes that the
results of the study confirm that Labopharm's once-daily tramadol given once
daily is an efficacious and safe treatment for pain due to osteoarthritis.
An online version of the article is available for download at
http://www.sciencedirect.com (fee of US$30).
Labopharm Secures Partner for Once-Daily Tramadol in Israel
Labopharm also announced that it has completed a licensing and
distribution agreement for Israel for its once-daily tramadol product with
Dexcel Pharma Technologies Ltd. Under the terms of the agreement, Dexcel will
have the exclusive right to market and sell Labopharm's once-daily tramadol
product in Israel. Labopharm will supply Dexcel with product and will receive
revenue at rates commensurate with those of previous licensing and
distribution agreements that Labopharm has entered into for European markets.
Labopharm will also receive an up front payment.
Dexcel (a Dexxon Company) is a research-based international specialty
pharmaceutical company dedicated to treating and preventing human disease
through discovery, development, manufacturing and commercialization of
innovative pharmaceutical products based on sophisticated proprietary
controlled-release oral solid dosage form drug delivery technologies. Dexcel's
products treat conditions in the largest therapeutic markets, including
Cardiovascular (CVS), Gastroenterology (GE), Central Nervous System (CNS) and
Dental Health Care. The company markets more than 65 products in more than
Labopharm's once-daily formulation of tramadol is currently under
regulatory review in Israel. The Company expects a response from the Israeli
regulatory authority by mid-2008.
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 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
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 regulatory process and the
commercialization of the Company's products, if they are approved,
specifically, the adoption of such products by physicians and patients.
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, firstname.lastname@example.org; French: Eric
Bouchard, Tel: (514) 208-5939, email@example.com