FDA Denies Labopharm's Appeal of Tramadol Approvable Letter

The FDA has rejected in writing Labopharm’s appeal of a second approvable letter the agency sent for the once-daily formulation of tramadol, a weak opioid used to treat pain.

But according to the company, John Jenkins, director of CDER’s Office of New Drugs, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements.”

The statistical method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.

Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.