Labopharm Initiates U.S. Phase III Clinical Trials for Once-Daily Tramadol
- Global Tramadol Development Program on Track for U.S. and European
Registration Filings in 2003 -
LAVAL, QC, Jan. 13 /CNW/ - Labopharm Inc. (TSX: DDS) today announced the
initiation of two Phase III clinical trials in the U.S. for its lead in-house
product, a once-daily formulation of Tramadol. Currently available in the U.S.
only in immediate-release forms that require dosing four to six times daily,
Tramadol generates annual U.S. sales of approximately US$740 million.
Labopharm is conducting two double blind, multi-centre, randomized trials
to evaluate the efficacy of once-daily Tramadol in reducing moderate to
moderately severe pain in patients suffering from osteoarthritis. The subject
population will include men and women aged 40 to 75 and patient dosing will
last for 12 weeks. The Company expects to complete the trials by the end of
2003, and the U.S. trial data, in conjunction with the data from ongoing and
completed studies, will form the New Drug Application (NDA) filing to the FDA.
"The on schedule initiation of the U.S. studies represents another major
step forward in our efforts to bring Tramadol to market globally," said James
R. Howard-Tripp, President and CEO of Labopharm. "Consistent with our plan, we
expect to file a drug registration dossier in Europe in the first quarter of
2003 followed by an NDA filing in the U.S. by the end of the year."
Tramadol is a centrally acting analgesic indicated for moderate to
moderately severe pain, which may be associated with such conditions as
osteoarthritis, lower back spasm, and other chronic conditions. It reduces
pain by binding to u-opioid receptors and by inhibiting the re-uptake of the
neurotransmitters norepinephrine and serotonin, offering a unique advantage
over other analgesics. Mr. Howard-Tripp noted, "Because Tramadol is well
tolerated compared to anti-inflammatory drugs, it can be used by patients who
are at risk of developing gastrointestinal bleeding and those with kidney
problems. We look forward to bringing the convenience of once-daily dosing of
Tramadol's proven therapeutic benefits to these and other patients." Current
worldwide sales of Tramadol are estimated to be in excess of US$1.3 billion
annually.
About Labopharm Inc.
Labopharm Inc. is an international pharmaceutical company specializing in
the development of drugs using the Company's advanced controlled-release
technology. Labopharm's core technology, Contramid(R), can be applied to a
wide variety of drugs in solid oral dosage form, in order to improve their
oral administration and performance. Labopharm's proprietary technology is
used to develop products that are either bio-equivalent to existing, branded
products or are new branded products that improve on existing products by
providing the therapeutic benefits of controlled-release drug delivery.
Labopharm is a public company whose common shares trade on the Toronto Stock
Exchange under the ticker symbol "DDS".
This press release contains forward-looking statements, which reflect the
Corporation'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 successful and timely completion of clinical
studies, the uncertainties related to the regulatory process and the
commercialization of the drug thereafter. Investors should consult the
Corporation'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 Corporation disclaims any obligation to update these
forward-looking statements.
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For further information: At Labopharm: James Howard-Tripp, President and
CEO, Labopharm, Tel: (450) 686-1017, jhoward-tripp@labopharm.com; At The
Equicom Group: Jason Hogan - Toronto, Investor Relations, Tel: (416) 815-0700,
jhogan@equicomgroup.com; At Feinstein Kean Healthcare: Harriet Ullman -
United States, Media and Investor Relations, Tel: (617) 577-8110,
hullman@fkhealth.com; At National Public Relations: Nathalie Bourque -
Montreal, Investor Relations, Tel: (514) 843-7171, nbourque@national.ca |
