FDA Plays

[rodster73]

LAVAL, QC and PRINCETON, NJ, Feb. 3, 2010 (Canada NewsWire via COMTEX) -- -
Second U.S. FDA Product Approval in Just Over a Year For Labopharm's
CONTRAMID(R) Controlled Release Technology -

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug
Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended
Release Tablets, a novel once-daily formulation of the antidepressant trazodone,
for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM)
utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls
the release of active substances within oral medications.

"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product
to receive FDA approval in just over a year," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "We are excited about the
opportunity for OLEPTRO(TM) and are preparing the product for launch into the
$11 billion-plus U.S. antidepressant market. We are working towards finalizing a
commercialization path for OLEPTRO(TM) that will maximize the value of our
product in this market."

MDD is a common mental illness often characterized by a combination of social
and somatic symptoms. It affects more than 14 million adults in the U.S. and is
the leading cause of disability globally. OLEPTRO(TM) will offer physicians
another therapeutic alternative for their MDD patients.

"There's a large body of evidence demonstrating the efficacy of trazodone in the
treatment of MDD," said Dr. Stephen Stahl, Adjunct Professor of Psychiatry,
University of California, San Diego School of Medicine. "Labopharm has developed
a novel formulation of trazodone that effectively treats depression and provides
a tolerable adverse event profile."

Labopharm is actively exploring several alternatives for the U.S.
commercialization of OLEPTRO(TM). Such alternatives range from out-licensing the
product to a distribution partner while retaining the right to some degree of
co-promotion, through to a full co-promotion arrangement under which Labopharm
would share the sales function with a partner. The Company currently expects to
finalize the commercialization plan for OLEPTRO(TM) in the near term.

Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S. later
this year, with specific timing for its launch to be determined within the
context of the final commercialization plan. The Company believes it is well
advanced in its preparations for the U.S. launch of OLEPTRO(TM). The Company has
completed market research with physicians and third-party payors, developed a
positioning and marketing campaign for OLEPTRO(TM), and finalized product
manufacturing and packaging arrangements.

About the OLEPTRO(TM) Pivotal Study

An eight-week randomized, double-blind, two-arm, multi-centre study in patients
with unipolar major depressive disorder demonstrated OLEPTRO(TM)'s efficacy as a
treatment for depression. The primary efficacy endpoint of the study was to
compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total
score from baseline to the end of the study in the OLEPTRO(TM) group versus the
placebo group. The results of this study, which are published in the May 2009
issue of Psychiatry, include the following:





<<

- Statistical significance was achieved for the primary endpoint

(p value of 0.012).

- The overall discontinuation rate in the study was 25 percent with

21 percent in the placebo group and 30 percent in the OLEPTRO(TM)

group.

- In the OLEPTRO(TM) group, four percent of patients discontinued

treatment due to somnolence or sedation.

>>



"Our research in the clinical study leading up to FDA approval showed that
OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater
improvement in the HAMD-17 primary efficacy end point over placebo," said Dr.
David Sheehan, University Health Professor and Director of the Depression and
Anxiety Disorders Research Institute, University of South Florida College of
Medicine. "When given at the recommended daily dose range, OLEPTRO(TM) was an
appropriate monotherapy for patients with MDD."

Labopharm will conduct a post-approval pediatric study. The FDA has asked
Labopharm to provide data from a long-term maintenance study and an additional
in-vitro alcohol dissolution study.

About Major Depressive Disorder

Approximately two times more prevalent in women than men, MDD often co-exists
with other illnesses. Research shows that only approximately 65 percent of
individuals with MDD are diagnosed and, of those patients, 90 percent are
treated with medication.

Treating MDD with antidepressant medications 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. Reasons for
discontinuing antidepressant treatment can include suboptimal efficacy, the
exacerbation of symptoms such as sleep disturbance, agitation, and sexual
dysfunction, and adverse events such as weight gain.

The FDA's decision represents the first regulatory approval for Labopharm's
novel, once-daily formulation of trazodone. The formulation is currently under
regulatory review in Canada.

Important Safety Information About Treatment with OLEPTRO(TM)

For more complete information about the use of OLEPTRO(TM), please see the
FDA-approved Prescribing Information and Medication Guide which will be posted
on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/).





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Black Box Warning

Warning: Suicidality and Antidepressant Drugs

See full prescribing information for complete boxed warning

Increased risk of suicidal thinking and behavior in children, adolescents

and young adults taking antidepressants for major depressive disorder

(MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for

use in pediatric patients.



Warning and Precautions



- Patients with major depressive disorder (MDD), both adult and

pediatric, may experience worsening of their depression and/or the

emergence of suicidal ideation and behaviour, or unusual change in

behaviour, whether or not they are taking antidepressant medications.

Patients should be monitored for clinical worsening and suicidality

and for the appearance of any of the following symptoms: anxiety,

agitation, panic attacks, insomnia, irritability, hostility,

aggressiveness, impulsivity, akathisia, hypomania, and mania.

Families and caregivers should be alerted about the need to monitor

patients.

- The development of a potentially life-threatening serotonin syndrome,

or neuroleptic malignant syndrome (NMS)-like reactions has been

reported with antidepressants, and may occur with OLEPTRO(TM),

particularly with concomitant use of other serotoninergic drugs.

Treatment with OLEPTRO(TM) and any concomitant serotonergic or

antidopaminergic agents, including antipsychotics, should be

discontinued immediately and supportive treatment should be

initiated.

- A major depressive episode may be the initial presentation of bipolar

disorder. Prior to initiating treatment, patients should be

adequately screened to determine if they are at risk for bipolar

disorder and monitored for mania/hypomania. OLEPTRO(TM) is not

approved for use in treating bipolar depression.

- Experience with administration of immediate-release trazodone

products indicates that there may be an increased risk for QT

interval prolongation. QT prolongation may lead to Torsades de

pointes and even death especially in susceptible individuals, such as

those with hypokalemia, hypomagnesemia, or a genetic predisposition

to prolonged QT/QTc.

- Patients with pre-existing cardiac disease may be at more risk for

arrythmias. Concomitant administration of drugs that prolong the QT

interval or that are inhibitors of CYP3A4 may increase the risk of

cardiac arrhythmia in these patients.

- Orthostatic hypotension and syncope have been reported in patients

receiving trazodone hydrochloride.

- Drugs that interfere with serotonin reuptake, including trazodone

hydrochloride may increase the risk of bleeding events. Concomitant

use with NSAIDs, aspirin, or other drugs that affect coagulation may

compound this risk.

- Serious, sometimes fatal, reactions have been reported when

serotonergic drugs are used in combination with monoamine oxidase

inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly

or within 14 days of monoamine oxidase inhibitors.

- Rarely, cases of priapism can occur in men receiving trazodone.

OLEPTRO(TM) should be used with caution in men who have predisposing

conditions.

- There is a risk of hyponatremia when taking antidepressants. Elderly

patients may be at greater risk, as well as patients taking diuretics

or who are volume-depleted.

- OLEPTRO(TM) has the potential to impair judgment, thinking, and motor

skills. Advise patients to use caution before driving and when

operating machinery.

- Discontinuation symptoms may occur with abrupt discontinuation, and

may include anxiety, agitation and sleep disturbance. Upon

discontinuation, taper OLEPTRO(TM) and monitor for symptoms.

>>



Adverse Reactions

The most common adverse reactions (incidence greater than or equal to five
percent and twice that of placebo) are: somnolence/sedation, dizziness,
constipation, blurred vision.

These are not all the possible adverse events of OLEPTRO(TM).

About Labopharm Inc.

Headquartered in Laval, Canada with US offices in Princeton, New Jersey,
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. Its second product, OLEPTRO(TM), a novel
formulation of trazodone for the treatment of major depressive disorder in
adults, has received regulatory approval in the U.S. and is under regulatory
review in Canada. Labopharm has initiated the European regulatory approval
process for its third product, a twice-daily formulation of
tramadol-acetaminophen. 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.