Labopharm gets FDA OK to submit once-daily tramadol

Looking for new drugs to replace Vioxx, the FDA has dropped its request for a new Phase III trial of Labopharm's once-daily tramadol pain reliever and is ready to review the data on hand. The decision advances Labopharm's chances of gaining a much speedier approval of the drug. Labopharm's stock immediately rose on the news. An ongoing Phase III trial will be expanded, though, to provide additional data for marketing purposes. The FDA's decision follows its approval of Biovail's rival once-daily tramadol, which will be jointly marketed by a unit of Johnson & Johnson. Now analysts see a looming marketing battle for market share.

- read this report from the Toronto Star for more information