- Article Discussing Pharmacokinetics and Dose Proportionality of
Company's Once-Daily Tramadol to be Published in Biopharmaceutics
LAVAL, QC, June 29 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that it will present a poster discussing the dose titration of its
once-daily formulation of tramadol at the 3rd International Forum on Pain
Medicine to be held June 28 to July 1, 2007 in Montréal, Canada.
The poster compares two different titration schedules for Labopharm's
once-daily formulation of tramadol in three Phase III clinical trials: a
six-day titration to a 300 mg dose (clinical trials MDT3-002 and MDT3-003) and
a nine-day titration to a 300 mg dose (clinical trial MDT3-005). The
comparison showed that percentage of adverse events and discontinuations due
to adverse events was similar regardless of the titration schedule.
These results, in addition to the fact that Labopharm's once-daily
tramadol formulation achieves steady state plasma levels after two days,
suggest that a shorter titration schedule may be adequate for most patients. A
previous study showed that most patients achieve pain control using
Labopharm's once-daily tramadol at a dose of 200 mg. The data in this poster
suggest that, for most patients, after starting with a dose of 100 mg for two
days, the therapeutic dose of 200 mg could be achieved after two days without
increased risk of side effects. If a patient requires a higher dose (300 mg),
the therapeutic dose could be achieved after six days of titration (100 mg for
2 days; 200 mg for 3 days then 300 mg on the 6th day) without increased risk
of side effects.
"The results of the comparison of titration periods reviewed in the
poster suggest that patients may benefit from rapid titration to optimal
analgesia without increased risk of side effects using our product," said
James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.
"The ability to quickly titrate patients to the optimal dose will be an
important competitive strength for our product in the marketplace."
The poster will be available on Labopharm's web site (www.labopharm.com)
on Monday, July 2, 2007 following conclusion of the Forum.
In addition, representatives of the Company will be at Labopharm's
corporate booth to promote its once-daily tramadol product to medical
professionals from around the world, as well as to generate awareness of
Labopharm's drug optimization technologies.
Labopharm also announced today that an article discussing the Company's
study to characterize the pharmacokinetics and to assess the dose
proportionality of 100 mg, 200 mg and 300 mg strengths of its once-daily
formulation of tramadol will be published in the September 2007 edition of the
journal Biopharmaceutics and Drug Disposition (Volume 28, Issue 6, Pages
323-330). An advanced online version of the article is available now at
basis, fee of US$25).
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.
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 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