Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy

Labopharm Inc. today announced that it has appealed the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level under the FDA's Formal Dispute Resolution process. Labopharm's continuation of the appeal process follows the completion of additional statistical analysis of existing data per the suggestion of Dr. John K. Jenkins, M.D., the FDA's Director for the Office of New Drugs, Center for Drug Evaluation and Research, as a means to potentially satisfy the FDA's requirements for regulatory approval. The Company believes that the additional analysis confirms the conclusions of efficacy of its once-daily tramadol formulation as demonstrated in previous analyses that were included in its New Drug Application (NDA) and additional submissions thereafter.

"We have maintained the position that our strong body of data warrants the approval of our once-daily tramadol formulation and believe that the additional analysis we conducted as proposed by the FDA confirms our position," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that continuing the Formal Dispute Resolution process, as opposed to submitting a complete response, is the most appropriate path to resolving the outstanding matter and achieving our objective of commercialization in the United States."
As part of the appeal process, Labopharm has requested a meeting with Dr. Janet Woodcock, M.D., the FDA's Director, Center for Drug Evaluation and Research. The Agency usually grants such requests within 30 days and typically provides a written response to the appellant within 30 days of a meeting.