Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted a complete response to the approvable letter issued by the U.S. Food and Drug Administration (FDA) for the Company?s once-daily formulation of tramadol.
Labopharm?s response includes additional analysis of its existing data. In its response, Labopharm believes it has addressed all of the matters raised by the FDA in the approvable letter. Upon acceptance for review of the response, the FDA will assign anaction date under the Prescription Drug User Fee Act (PDUFA).
The Company has concurrently appealed the action taken by the FDA in its approvable letter utilizing the Formal Dispute Resolution process. Labopharm received the approvable letter for its once-daily formulation of tramadol on September 28, 2006 following submission of its New Drug Application on November 28, 2005.
“Based on discussions with the FDA and our regulatory advisors, we believe that this two-pronged approach will provide the most expeditious path forward as we pursue final regulatory approval in the U.S.,” said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.
Labopharm?s NDA for once-daily tramadol included data from the Company?s global clinical development program including six Phase III clinical studies and 12 pharmacokinetic studies. Combined, more than 2400 patients have been exposed to the product in clinical studies.