Labopharm Inc announced the US 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, Labopharm's clinically validated technology that controls the release of active substances within oral medications.

"Oleptro represents Labopharm's second Contramid technology-based product to receive US 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 US$ 11 billion-plus US 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 US 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 US 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 US 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 US 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.

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.

"Our research in the clinical study leading up to US 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 paediatric study. The US FDA has asked Labopharm to provide data from a long-term maintenance study and an additional in-vitro alcohol dissolution study.

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.