Another FDA delay for Labopharm pain drug

(Reuters) - The FDA said Labopharm had not demonstrated the efficacy of
its once-daily formulation of tramadol because statistical
methods used to analyze data from clinical trials did not
adequately address missing data relating to those who dropped
out and did not complete the study, the company said.




Labopharm said the agency did not explain how the
statistical methods were inadequate, adding that it hopes to
clarify the issue with the FDA at the earliest possible
opportunity.


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