Labopharm Files NDS For Trazodone With Health Canada

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

The company’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 study in patients with major unipolar depressive disorder, demonstrated the efficacy of Labopharm’s formulation as a treatment for depression. It also showed positive effect on the quality of sleep, said the company.

James Howard-Tripp, president and CEO, Labopharm, said: We are pleased to file our New Drug Submission to Health Canada.We believe the $800m-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.