- Novel Formulation Has Potential to Address Unmet Need in Global
Anti-Depressant Market -
LAVAL, QC, Sept. 22 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that it has submitted a New Drug Application (NDA) under Section
505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug
Administration (FDA) for DDS-04A, a once-daily serotonin antagonist reuptake
inhibitor (SARI) that provides an effective alternative in the treatment of
"According to published market data and a survey of more than 300 primary
care physicians and psychiatrists, the slow onset of action, coupled with
increased anxiety, sleep disturbance and unwanted side effects, such as weight
gain and sexual dysfunction, are cited as the primary reasons why patients
discontinue existing treatments early," said James R. Howard-Tripp, President
and Chief Executive Officer, Labopharm Inc. "The profile of our formulation
addresses these concerns and we believe that may allow us to capture a
significant share of the global anti-depressant market."
Major depression is one of the most prevalent central nervous disorders,
affecting more than 120 million people worldwide. In 2007, $19 billion worth
of anti-depressants were prescribed globally, with more than $12 billion in
the U.S. According to the World Health Organization 40% of patients treated
with current medications may discontinue treatment within the first 12 weeks
due to limitations with existing products and their unwanted side effects.
Labopharm's NDA for its novel antidepressant formulation containing
trazodone is based on data from five pivotal pharmacokinetic studies and the
positive results from its North American Phase III placebo controlled clinical
trial (study 04ACL3-001), which enrolled more than 400 patients. In the Phase
III study, the primary endpoint achieved statistical significance providing an
improvement from baseline to the end of the study as measured by the Hamilton
Rating Scale for Depression (HAMD-17). Patients experienced rapid onset of
action as demonstrated by a clinically significant improvement in HAMD scores
within the first two weeks of treatment. In addition, the study demonstrated
an improvement in the overall quality of sleep and a favourable adverse event
profile, including transient mild to moderate somnolence, no difference from
placebo in anxiety, agitation, sexual dysfunction and weight change.
Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act
typically applies to reformulations of drugs that are already approved and
being marketed, allowing the Company to refer to existing efficacy and safety
data on trazodone. The Agency advised the Company that one positive Phase III
study is required for the formulation to be approved.
In addition to the U.S., Labopharm plans to pursue regulatory approval
for DDS-04A in Canada and other markets worldwide for which it holds the
rights under a cross-licensing agreement with Gruppo Angelini. Under the terms
of the agreement, Labopharm has the rights to commercialize its formulation in
the U.S., (the largest market for trazodone) and Canada in addition to most
other countries outside Europe. Gruppo Angelini, has the rights to
commercialize in Europe and some Asian markets.
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,