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Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
LAVAL, QC, May 31, 2007 /PRNewswire-FirstCall via COMTEX/ -- Labopharm Inc. today announced that it has received a second approvable letter from the U.S. Food and Drug Administration (FDA) for its once-daily formulation of tramadol.
In the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation of tramadol because 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 provide guidance with respect to how the statistical methods were not adequate. The Company will seek to clarify the issue with the FDA at the earliest possible opportunity.
"We are extremely disappointed by the FDA's assessment of our response to its initial approvable letter," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "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 U.S."
Labopharm plans to discuss the most recent approvable letter with the FDA as soon as possible to determine the appropriate path forward to achieve final approval. Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data.
Prior to the recent approvable letter, the FDA had indicated that it would not proceed with the Formal Dispute Resolution process, which was initiated by Labopharm last December, while the response to the September 28, 2006 approvable letter was under review. The Company will evaluate whether to proceed with the Formal Dispute Resolution process going forward.
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Purtroppo un altra vittima del pharm
Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
LAVAL, QC, May 31, 2007 /PRNewswire-FirstCall via COMTEX/ -- Labopharm Inc. today announced that it has received a second approvable letter from the U.S. Food and Drug Administration (FDA) for its once-daily formulation of tramadol.
In the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation of tramadol because 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 provide guidance with respect to how the statistical methods were not adequate. The Company will seek to clarify the issue with the FDA at the earliest possible opportunity.
"We are extremely disappointed by the FDA's assessment of our response to its initial approvable letter," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "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 U.S."
Labopharm plans to discuss the most recent approvable letter with the FDA as soon as possible to determine the appropriate path forward to achieve final approval. Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data.
Prior to the recent approvable letter, the FDA had indicated that it would not proceed with the Formal Dispute Resolution process, which was initiated by Labopharm last December, while the response to the September 28, 2006 approvable letter was under review. The Company will evaluate whether to proceed with the Formal Dispute Resolution process going forward.
About Labopharm Inc.
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