Labopharm is mounting a new regulatory appeal after the FDA refused to overturn its approvable letter for the once-daily version of tramadol. The developer mounted a formal appeal last month after regulators refused to approve the therapy pending certain conditions. And the Canadian company says it may have to submit additional data before it can get a formal approval. Labopharm says it's willing to take its appeal all the way to the top of the FDA chain of command. The agency has said that researchers failed to prove the drug is effective because they omitted data from patients who had dropped out of the study from their analysis.
There's a lot riding on the outcome. Labopharm shares quickly shed about half of their value after the FDA delivered its first approvable letter in the spring. It's now down about 65 percent off that mark.
- see this release
- check out the AP report