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news.Canadian drug developer Labopharm has reported that the FDA may require it to conduct an additional phase III clinical trial for its once-daily formulation of pain drug tramadol.
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The US agency said the company had not demonstrated the efficacy of the painkiller, because statistical analysis of data from the trials did not address missing data from patients who had dropped out of trials.
Labopharm said a meeting with the US agency had been “productive” and that “the statistical analysis required by the FDA to achieve approval has been clearly delineated.”