Labopharm says it will have to mount another trial of the pain drug tramadol if it can't gain FDA approval with existing data. The FDA has issued two approvable letters, noting that new data was needed. Regulators say that Labopharm's Phase III study of the once-daily therapy was flawed because its analysis failed to evaluate missing data from patients who had dropped out of the study.
- see this release for more
- read the AP report
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