Labopharm submits application to FDA for pain killer tramadol

By E. Janene Geiss

Philadelphia, Nov. 30 - Labopharm Inc. announced Wednesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for its once-daily formulation of the analgesic tramadol.

Labopharm is seeking regulatory approval to market its once-daily tramadol for the management of moderate to moderately severe pain, according to a company news release.

The action date under the Prescription Drug User Fee Act for Labopharm's NDA is Sept. 28, 2006, officials said.

Labopharm's NDA for its once-daily formulation of tramadol is based on comprehensive data generated by a global clinical package incorporating 11 pharmacokinetic studies and five phase 3 clinical studies.

The five phase 3 studies consist of two U.S. studies versus placebo, one European study versus an active comparator and two long-term safety studies. Nearly 2,000 patients were enrolled in the studies, officials said.

"Although previously the FDA had indicated that our submission would require an additional positive phase 3 study, that is no longer the case. Pending regulatory approval of this application, we look forward with our U.S. marketing partner, Purdue Pharma Products, LP to bringing our once-daily formulation of tramadol to the U.S. market," said James R. Howard-Tripp, president and chief executive officer, in the release.

The company said the FDA has indicated that its clinical package is sufficient for an NDA to be accepted for review and considered for approval.

Because Labopharm's third U.S. phase 3 efficacy trial for tramadol is no longer required, the company said it elected to expand enrollment to improve the power of the study in support of marketing efforts should the product receive marketing approval from the FDA, officials said.

Enrollment has been completed and the results are expected soon, officials said.

Labopharm, based in Laval, Quebec, is specialty pharmaceutical company focused on the development of drugs incorporating Contramid, the company's proprietary advanced controlled-release technology.

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