Labopharm shares took a nasty hit from investors after the company announced that the FDA had issued a second approvable letter for its once-daily formulation of the pain drug tramadol. The letter raises the prospect of a fresh set of delays as the company rushes to answer regulators' new queries. Labopharm said that it was possible that the FDA would need to see new data on tramadol before it could approve the drug. The FDA has been examining the trial data and said that efficacy hadn't been demonstrated because its statistical methods didn't address missing data regarding patients who had dropped out of the study. Labopharm is looking to clarify exactly what it is that the FDA is looking for. Labopharm said last January that it had addressed all the issues laid out by the FDA in its first approvable letter. Now it says it plans to meet with the FDA to find out more about the agency's new demands. None of that was what investors were looking to hear, though, as they sliced off 21 percent of Labopharm's share price in after-hours trading.
- see this release for more
- check out the AP report on tramadol