Canada's Labopharm receives US FDA approval for Oleptrol, which is now set to enter $11 billion US antidepressant market

The US Food and Drug Administration has approved Canadian company Labopharm's Oleptrol (trazodone hydrochloride) extended release tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. Oleptrol utilizes Contramid, Labopharm's clinically validated technology that controls the release of active substances within oral medications.

"Oleptrol represents Labopharm's second Contramid technology-based product to receive FDA approval in just over a year," said James Howard-Tripp, president and chief executive of Labopharm. "We are excited about the opportunity for Oleptrol and are preparing the product for launch into the $11 billion-plus US antidepressant market. We are working towards finalizing a commercialization path for Oleptrol that will maximize the value of our product in this market," he added.

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 USA and is the leading cause of disability globally. The drug will offer physicians another therapeutic alternative for their MDD patients, according to Labopharm.