Labopharm Inc. said it would have to conduct an additional Phase 3 trial for its once-daily version of painkiller Ultram(Tramadol), if existing data provided to the U.S. Food and Drug Administration failed to answer the board's concerns.
But a recent meeting with the regulator "was productive and that the statistical analysis required by the FDA to achieve approval has been clearly delineated," the company said in a release.
Late last month, the company received a second approvable letter from the FDA, signaling the medicine would not be approved until certain conditions are met. The company said it was possible the agency would require additional data before the drug could be approved.
The FDA said last month that Labopharm failed to demonstrate the efficacy of its once-daily formulation tramadol as the statistical methods used to analyze data from Labopharm's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials.
The FDA did not outline how the statistical methods were not adequat
But a recent meeting with the regulator "was productive and that the statistical analysis required by the FDA to achieve approval has been clearly delineated," the company said in a release.
Late last month, the company received a second approvable letter from the FDA, signaling the medicine would not be approved until certain conditions are met. The company said it was possible the agency would require additional data before the drug could be approved.
The FDA said last month that Labopharm failed to demonstrate the efficacy of its once-daily formulation tramadol as the statistical methods used to analyze data from Labopharm's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials.
The FDA did not outline how the statistical methods were not adequat