LAVAL, QC, Jan. 22 /CNW/ - Labopharm Inc. (TSX: DDS) today announced
positive results from the recently completed multi-centre European Phase III
clinical trial for its lead in-house product, a once-daily formulation of the
analgesic, tramadol. Tramadol is indicated for the treatment of moderate to
moderately severe pain and is currently available in immediate release
(four- to six-times daily) forms in the United States and predominantly as
extended release, twice-daily forms in Europe. Tramadol currently generates
worldwide sales in excess of US$1.3 billion.
Highlights
- Labopharm's once-daily formulation of tramadol achieved the primary
end point of the study, providing a statistically and clinically
significant reduction in pain associated with osteoarthritis.
- Labopharm's once-daily tramadol demonstrated a superior adverse events
profile compared with that of the comparator, a twice-daily
formulation of tramadol currently marketed in Europe.
- Labopharm's once-daily tramadol provided sustained pain relief for a
full 24-hour period, matching the twice-daily formulation dosed twice
per day.
- Two-thirds of the patients receiving Labopharm's once-daily tramadol
required a dose of 200mg or less per day to achieve effective pain
relief.
"The positive results of this study firmly position us to take the final
steps in commercializing our first product," said Mr. James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "Combined with results
from earlier studies, we now have the required data to support our new drug
registration dossier filing in Europe, which we expect to submit on schedule
in the first quarter of calendar 2003. Moreover, the study results provide the
most significant validation to date of our proprietary technology,
Contramid(R), as well as our ability to rapidly move products from feasibility
through to registration filing."
Results of the Study
The double blind, randomized, parallel-group study was designed to
compare the efficacy and safety of Labopharm's once-daily formulation of
tramadol to that of an extended release, twice-daily formulation of tramadol
currently marketed in Europe. Patients with osteoarthritis of the knee
received treatment for 12 weeks at the individual's optimum dosage, ranging
from 100mg to 400mg daily, as determined through titration based on effective
pain relief and tolerability of adverse events. The primary end point of the
study was pain relief as measured on the WOMAC Osteoarthritis Index pain
subscale. Secondary end points included the reduction in stiffness and
improvement in physical function as measured on the WOMAC Index, the reduction
in pain intensity as measured on the pain Visual Analogue Scale (VAS), an
assessment of pain relief over a 24-hour period, the incidence of adverse
events, and the patient's and physician's global assessment of pain relief.
Labopharm's once-daily formulation of tramadol achieved the primary
endpoint of the study, providing statistically and clinically significant
reduction in pain associated with osteoarthritis. Pain relief was achieved
from the first week of treatment and was maintained and further improved over
the duration of the study. Two-thirds of the patients receiving Labopharm's
once-daily tramadol required a dose of 200mg or less per day to achieve
effective pain relief. Labopharm's once-daily tramadol also showed an
improvement in all secondary endpoints. Furthermore, the study demonstrated
that Labopharm's once-daily tramadol provided pain relief for a full 24-hour
period, matching the twice-daily formulation dosed twice per day.
The adverse events profile of Labopharm's once-daily tramadol was
superior to that of the twice-daily tramadol product with a lower incidence of
adverse events. Moreover, the difference was even more markedly in favour of
Labopharm's once daily formulation when compared to the incidence of adverse
events associated with immediate release tramadol as reported in the
literature.
Detailed study results are being held pending future publication or
presentation.
Additional Study Details
Enrollment in the study was 431 patients, aged 40 to 75 years, diagnosed
with moderate to moderately severe pain associated with osteoarthritis of the
knee. Patients who met the inclusion and exclusion criteria at screening
entered a three- to seven-day wash out period during which all analgesic use
was discontinued. At the start of the study (baseline), eligible patients who
reported pain intensity in the knee joint greater than 150 mm on the WOMAC
pain subscale (5 items) were randomly assigned to receive either Labopharm's
once-daily tramadol or a currently marketed twice-daily tramadol formulation.
An initial dose of 100mg daily was maintained for three days. Thereafter, if
required, the dose was increased every two to three days up to a maximum dose
of 400mg, based upon effective pain relief and tolerability of adverse events.
Patients were then maintained on their optimum dose for a 12-week period.
About Tramadol
Tramadol is a centrally acting analgesic indicated for moderate to
moderately severe pain, which may be associated with conditions such as
osteoarthritis, lower back spasm and other acute and chronic conditions.
Because it 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. Tramadol 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. The worldwide market for tramadol is estimated to be in excess of
US$1.3 billion annually.
Conference Call
Labopharm Inc. will host a conference call today (Wednesday,
January 22nd, 2003) at 8:30 a.m. (ET) to discuss today's announcement. To
access the conference call by telephone, dial 416-405-9328 or 1-800-387-6216.
Please connect approximately five minutes prior to the beginning of the call
to ensure your participation. The conference call will be archived for replay
until Wednesday, January 29, 2003 at midnight. To access the archived
conference call, dial 416-695-5800 or 1-800-408-3053 and enter the pass code
1360095.
A live audio webcast of the conference call will be available at
www.labopharm.com and www.financialdisclosure.ca. Please connect at least 15
minutes prior to the conference call to ensure adequate time for any software
download that may be required to join the webcast. The webcast will be
archived at the above web sites for 90 days.
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 |
