Labopharm (DDSS) Receives Response From FDA After Appeal of 'Approvable Letter'

June 30, 2008 7:38 AM EDT

Labopharm Inc. (NASDAQ: DDSS) has received a response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process.

Procedurally, Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal. However, he suggested a regulatory path forward. Dr. Throckmorton has suggested that the Company submit the analysis put forward by Dr. Jenkins in his letter of earlier this year. In the response, the FDA has concluded that a positive finding using this analysis could provide the needed assurance to support the efficacy of Labopharm's once-daily tramadol. Following resolution of any issues with labeling, such a finding would lead to the approval of the product.

The Company expects to submit the complete response before the end of the week and the FDA has agreed to conduct its review of the response in a timely basis.

Labopharm has completed the statistical analysis of data suggested by Dr. Jenkins and believes that the findings confirm the conclusions of efficacy of its once-daily tramadol formulation.[SM]

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