Company Believes Robust Clinical Data Package Provided in NDA
Demonstrates Efficacy and Safety of Once-Daily Tramadol Formulation
LAVAL, QC, Sept. 24 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that is has requested a meeting with the U.S. Food and Drug
Administration (FDA), regarding the Company's New Drug Application (NDA) for
its once-daily formulation of tramadol. Based on additional analysis that
Labopharm has performed, as well as further discussions with its regulatory
advisors, the Company believes that it has demonstrated the efficacy and
safety of its once-daily tramadol formulation.
Based on data from the Company's global clinical trial program submitted
with the NDA, including a positive Phase III study conducted in accordance
with a Special Protocol Assessment, Labopharm strongly believes that it has
provided the FDA with more than adequate evidence of the efficacy and safety
of its once-daily formulation of tramadol.
Should Labopharm and the Agency fail to mutually agree on a path forward
toward final regulatory approval, or should the FDA not grant the meeting
within the next 30 days, Labopharm plans to appeal the FDA's current decision
through the Agency's Formal Dispute Resolution process.
Labopharm's NDA for once-daily tramadol included data from the Company's
global clinical development program including six Phase III clinical studies
and 12 pharmacokinetic studies. Combined, more than 2400 patients have been
exposed to Labopharm's once-daily tramadol in clinical studies.
About the FDA's Formal Dispute Resolution Process
FDA regulations provide a mechanism for those seeking regulatory approval
of a drug product through a New Drug Application (NDA) to obtain formal review
of any Agency decision through a Formal Dispute Resolution process by raising
the matter with the supervisor of the employee who made the decision. If the
issue is not resolved at the primary supervisory level, the applicant may
request that the matter be reviewed at the next higher supervisory level. This
process may continue through the Agency's chain of command, through the
Centers to the Commissioner of Food and Drugs. The Formal Dispute Resolution
process exists to encourage open, prompt discussion of scientific (including
medical) disputes and procedural (including administrative) disputes that
arise during the drug development, new drug review, generic drug review, and
post-marketing oversight processes.
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 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, email@example.com; French: Eric
Bouchard, Tel: (514) 844-7997, firstname.lastname@example.org