As part of the appeal process, Labopharm has requested a meeting with Janet Woodcock, 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.
Labopharm’s continuation of the appeal process follows the completion of additional statistical analysis of existing data as per the suggestion of John Jenkins, 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 and additional submissions thereafter.
James Howard-Tripp, president and CEO of Labopharm, said: “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 US.”