Labopharm receives FDA approval for Oleptro

Princeton, NJ — Labopharm Inc. today 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, 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 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.