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Labopharm Receives FDA Approval For OLEPTRO™
Second U.S. FDA Product Approval in Just Over a Year For Labopharm's CONTRAMID(R) Controlled Release Technology
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February 4, 2010 - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO™ (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™ utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.
"OLEPTRO™ 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™ 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™ 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™ 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™. 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™ in the near term.
Labopharm expects OLEPTRO™ 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™. The Company has completed market research with physicians and third-party payors, developed a positioning and marketing campaign for OLEPTRO™, and finalized product manufacturing and packaging arrangements.
About the OLEPTRO™ Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in patients with unipolar major depressive disorder demonstrated OLEPTRO™'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™ 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™ group.
- In the OLEPTRO™ 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™ 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™ 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™
For more complete information about the use of OLEPTRO™, please see the FDA-approved Prescribing Information and Medication Guide which will be posted on the FDA website (www.accessdata.fda.gov/Scripts/cder/DrugsatFDA).
For More Information Contact :
Mark D'Souza
Senior Vice-President and Chief Financial Officer
Tel: (450) 686-0207
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