Labopharm Receives FDA Approval For OLEPTRO
Labopharm Inc. 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."
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.
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