Labopharm's novel trazodone formulation subject of publication in peer-reviewed medical journal
LAVAL, QC, Nov. 10 /PRNewswire-FirstCall/ -- Labopharm Inc.
(TSX: DDS; NASDAQ: DDSS) today announced an article has been
published in the international journal of neuropsychiatric
medicine, CNS Spectrums October, 2009 issue (www.cnsspectrums.com),
citing the potential benefit of its novel trazodone formulation,
which contains Contramid(R). Labopharm's Contramid is the
clinically validated proprietary technology that controls the
release of active substances from oral medications to optimize drug
delivery.
The article is authored by Dr. Stephen Stahl, adjunct professor
of psychiatry, University of California, San Diego School of
Medicine as part of a series entitled Trends in Psychopharmacology,
the Mechanism of Action of Trazodone: A Multifunctional Drug.
"Although trazodone has traditionally been used as a low dose
hypnotic, a new controlled release formulation that has the
potential to improve the tolerability of high doses may provide an
opportunity to revisit this multifunctional drug as an
antidepressant as well," writes Dr. Stahl in the article's
abstract.
The article states that high doses of trazodone must be
delivered to take advantage of the multifunctional activity of the
drug. Contramid technology contained within the controlled-release
trazodone tablet is designed to maintain plasma concentrations of
the drug at levels high enough to inhibit serotonin re-uptake,
providing antidepressant effects, while simultaneously blocking
5HT2A and 5-HT2C receptors. Blocking these receptors is thought to
avoid side effects such as sexual dysfunction, weight gain and
development or exacerbation of anxiety often seen with other
antidepressant drugs. Controlled-release trazodone containing
Contramid was designed to avoid peak blood levels of trazodone
associated with multiple administrations of immediate-release
formulations. Such peak levels are thought to affect tolerability
and possibly result in the intolerable sedation seen in some
patients.
"Controlled-release trazodone should theoretically allow
adequate dose escalation to administer high doses for
antidepressant action while avoiding sedation of the immediate
release formulation," concludes Dr. Stahl. "As an antidepressant,
the new trazodone formulation should be as effective as selective
serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine
reuptake inhibitors (SNRIs), yet as a serotonin antagonist reuptake
inhibitor (SARI), have a low incidence of anxiety, insomnia and
sexual dysfunction."
The efficacy and safety profile of Labopharm's controlled
release trazodone formulation has been demonstrated in a
placebo-controlled phase III study, the results of which were
discussed in a separate article entitled Extended Release Trazodone
in Major Depressive Disorder: A Randomized, Double-Blind,
Placebo-Controlled Study, which was published in the May 2009 issue
of the peer-reviewed journal Psychiatry (Edgemont) (Volume 6,
Number 5) (www.psychiatrymmc.com).
About Labopharm's Novel Trazodone Formulation
Major depressive disorder (MDD) is a common mental illness often
characterized by a combination of symptoms that interfere with a
person's ability to work, sleep, study, eat, and enjoy
once-pleasurable activities. Treating MDD with antidepressants is
challenging for physicians because patient response to
antidepressant drug therapy varies significantly. Research has
shown that as many as 28 percent of patients being treated with
antidepressants stop taking their medication within the first four
weeks of treatment and as many as 44 percent stop within the first
12 weeks. Frequently cited reasons for discontinuing therapy
include suboptimal efficacy on depression symptoms, exacerbation of
sleep disturbance, increased agitation, slow onset of action,
sexual dysfunction and weight gain.
Trazodone is a serotonin antagonist reuptake inhibitor (SARI)
with proven efficacy as an antidepressant. Labopharm's novel
formulation of trazodone is a controlled release formulation
designed to optimize the efficacy of trazodone, and address the
major challenges in treating depression.
Labopharm's trazodone formulation is currently under regulatory
review in both the United States and Canada.
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 now available in 17
countries around the world, including the U.S., Canada, major
European markets and Australia. The Company's second product, a
novel formulation of trazodone for the treatment of major
depressive disorder, is under regulatory review in the U.S. and
Canada. The Company also has a 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
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 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. Except as required by law, the Company undertakes no
obligation and does not intend to update these forward-looking
statements.
Source: Labopharm Inc.
CONTACT: 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, jhogan@equicomgroup.com;
French: Joe Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com
