You are here
Additional Phase 3 Study To Be Conducted for Once-Daily Tramadol
"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 R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.
MDT3-005 Trial Protocol
MDT3-005 is a double-blind, randomized study to compare the safety and efficacy of Labopharm's once-daily formulation of tramadol to placebo over a 12-week period in patients with osteoarthritis of the knee. The study will be conducted at more than 50 centres across the U.S. and Canada and will include more than 500 subjects. The Company is negotiating a Special Protocol Assessment (SPA) for MDT3-005 with the FDA. An SPA is a binding agreement between the FDA and the sponsor of a clinical trial stating that the study design meets the scientific and regulatory requirements of the FDA to support an NDA submission.
"To maximize the probability of a successful outcome, the protocol of MDT3-005 differs from the previous U.S. Phase III trials for our once-daily tramadol product, resembling more closely that of the positive European Phase III study," said Mr. Howard-Tripp. "Securing an SPA will confirm that the study design is acceptable to the FDA and, should the study achieve the desired results, will be considered a positive pivotal trial in our NDA submission."