Labopharm hit by second FDA letter

Quebec, Canada-based Labopharm has received a second "approvable" letter from the US Food and Drug Administration for its once-daily formulation of the painkiller tramadol. On the day this further delay was announced, June 1, shares in the firm nose-dived 50.1% to $3.14.

In its latest "approvable" letter, the FDA stated that Labopharm has not demonstrated the efficacy of the agent because the statistical methods used to analyze data from its clinical trials did not adequately address missing results relating to subjects who dropped out of the trials. The FDA did not provide guidance with respect to how the statistical methods were not adequate.

"We are extremely disappointed by the FDA's assessment of our response to its initial approvable letter," said James Howard-Tripp, the firm's chief executive. "We believe that we adequately addressed all of the matters raised by the FDA in its first approvable letter. Our top priority remains the final approval of our once-daily tramadol in the USA." Labopharm plans to discuss the most recent letter with the FDA as soon as possible to determine the appropriate path to approval. Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data, the firm stated.