Labopharm Falls on FDA Letter

The regulatory agency says the drugmaker hasn't demonstrated the efficacy of pain-reliever Tramadol.
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plunged 53% Friday morning on news that the Food and Drug Administration issued a second approvable letter saying the specialty pharmaceutical company hasn't demonstrated the efficacy of its once-daily formulation of pain-reliever Tramadol.

The FDA said that the statistical method used to analyze the data from the clinical trials didn't address missing data on subjects who dropped out of the trials. Labopharm said the FDA didn't explain how the statistical methods weren't adequate.

Chief Executive James Howard-Tripp said the company feels it adequately addressed all of the FDA's concerns in its first approvable letter. "We are extremely disappointed by the FDA's assessment of our response to its initial approvable letter."

Labopharm said it will try to clarify the problem with the regulatory agency as soon as possible. "Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data," the company said.

Shares were recently down $3.35, at $2.96.