Labopharm’s new drug application (NDA) for its novel antidepressant formulation containing trazodone is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients.
In addition to the US, Labopharm plans to pursue regulatory approval for DDS-04A in Canada and other markets worldwide for which it holds the rights under a cross-licensing agreement with Gruppo Angelini.
Under the terms of the agreement, Labopharm has the rights to commercialize its formulation in the US and Canada in addition to most other countries outside Europe. Gruppo Angelini has the rights to commercialize in Europe and some Asian markets.
James Howard-Tripp, president and CEO of Labopharm, said: “The profile of our formulation addresses these concerns and we believe that may allow us to capture a significant share of the global anti-depressant market.”