The 12-week trial will compare the safety and efficacy of tramadol with that of placebo in more than 500 patients with osteoarthritis of the knee. Enrollment is expected to begin in the fourth quarter of this year.
“While data to date from our global clinical trial program demonstrate the safety and efficacy of our product, based on discussions with the FDA and counsel from our regulatory advisors, we believe, as do our potential marketing partners, that the most efficient path to obtaining U.S. regulatory approval is to conduct an additional pivotal trial,” said James Howard-Tripp, president and chief executive officer of Labopharm.
The protocol of the upcoming trial will differ from Labopharm’s previous Phase III trials for the product, the company added.
Labopharm also announced a reprioritization of its product-development programs. The firm said it will continue to aggressively pursue development of once-daily formulations of trazadone and betahistine, but will slow its programs for a controlled-release formulation of gabapentin and a once-daily formulation of oxybutynin. Furthermore, Labopharm will terminate development of implantable Contramid mini-tablets as well as its joint program with Axcan Pharma Inc. for the development of a controlled-release formulation of trimebutine maleate.
Labopharm shares closed at $3.13, down $1.12, or 26.4 percent, in heavy trading on the Toronto Stock Exchange.