Labopharm Takes Appeal of FDA's Tramadol Action to the Next Level

Labopharm is continuing the formal dispute resolution process with the FDA over a second approvable letter issued for the firm’s controlled-release formulation of tramadol, a weak opioid used to treat pain.

Curtis Rosebraugh, acting director of the Office of Drug Evaluation II, recently rejected the company’s request to overturn the approvable letter, which was issued in May. Labopharm said it would submit the appeal in the coming weeks to John Jenkins, director of the Office of New Drugs.

Labopharm submitted a 505(b)(2) new drug application for the product to the FDA referencing the immediate-release version of tramadol, Johnson & Johnson’s (J&J) Ultram and generics. J&J markets the only U.S.-approved controlled-release formulation of tramadol, Biovail’s Ultram ER.

Labopharm’s application includes data from three Phase III clinical trials, one of which was conducted under a special protocol assessment and met its primary endpoint. The issue with the application is related to a statistical analysis of drop rates in the trial, the company said.

The company said the agency changed its approval standards for the drug in the middle of the application process. The firm emphasized that it followed the special protocol assessment, and the trial met its endpoint. The product is approved in several countries, including Canada, France, Germany, Spain, Italy and the UK.