Labopharm Inc has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone.

"We are pleased to file our New Drug Submission to Health Canada," said James R Howard-Tripp, president and chief executive officer, Labopharm Inc. "We believe the $800 million-plus Canadian market for antidepressants represents a significant opportunity for our trazodone formulation and we are currently in discussions with potential partners to support the commercialization of our product in Canada."

Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American phase-III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients.

The eight-week randomized, double-blind, two-arm, multi-centre phase-III study in patients with major unipolar depressive disorder demonstrated the efficacy of Labopharm's formulation as a treatment for depression, as well as its positive effect on quality of sleep.

Major depressive disorder (MDD) is a common mental illness often characterized by a combination of symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Approximately 8 per cent of adults will experience major depression at some time in their lives.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies.