The FDA has rejected Labopharm's appeal of the regulators' decision on once-daily tramadol, but kept the door open to an approval. If the company files an analysis that had been requested earlier, the FDA says it could be used to come up with a positive decision on the drug's efficacy--possibly paving the way to an approval. The FDA laid out conditions to an approval back in May of 2007 and the Canadian biotech has consistently maintained that it had already made its case for the drug. A full response to the FDA will be made by the end of the week and the agency has promised a timely review.
"We are encouraged by the agency's request to formally submit the data analysis that Dr. Jenkins suggested we undertake and believe that this is a positive step towards regulatory approval in the U.S.," said CEO James R. Howard-Tripp. "The request follows a meeting with the FDA, as well as constructive discussions over the past two months. We continue to believe that the comprehensive data generated by our global clinical trial program demonstrates the efficacy and safety of our once-daily tramadol formulation and that we have met the statutory standards for approval of our formulation."
- check out the press release
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