LAVAL, QC, July 2 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that it has submitted a complete response to the Food and Drug
Administration (FDA) per the suggestion of Dr. Douglas Throckmorton, M.D., the
FDA's Deputy Director, Center for Drug Evaluation and Research (CDER), as the
next step in the regulatory path towards potential U.S. approval of the
Company's once-daily formulation of tramadol. The complete response centers on
the additional analysis of existing data using the methodology put forward by
Dr. John K. Jenkins, M.D., Director for the Office of New Drugs, CDER, in his
letter earlier this year.
Upon acceptance for review of the response, the FDA will assign an action
date under the Prescription Drug User Fee Act (PDUFA).
About Labopharm's Once-Daily Tramadol Product
Labopharm's once-daily tramadol product is based on the Company's
proprietary Contramid(R) technology, which provides a dual matrix delivery
system allowing both rapid and sustained drug release that maintains blood
levels within the therapeutic range providing a full 24 hours of pain relief.
The Company believes that maintaining drug concentrations within the
therapeutic range has the advantage of fewer and less severe side effects
while maintaining efficacy. Under its global commercialization program,
Labopharm's once-daily tramadol product has been launched in 12 countries,
including the five largest markets in Europe and Canada and is approved in 19
other countries. Including those countries in which its product has been
launched, Labopharm has licensing and distribution agreements in place for
more than 50 markets 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 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 uncertainties related to the regulatory process in various
countries for the approval of the Company's products and the successful
commercialization of the products throughout the world 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,
firstname.lastname@example.org; French: Joe Racanelli, Tel: (514) 844-7997,