Company Believes Robust Clinical Data Package Provided in NDA Demonstrates
Efficacy and Safety of Once-Daily Tramadol Formulation
LAVAL, QC, Sept. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that is has requested a meeting with the U.S. Food and Drug Administration (FDA), regarding the Company's New Drug Application (NDA) for its once-daily formulation of tramadol. Based on additional analysis that Labopharm has performed, as well as further discussions with its regulatory advisors, the Company believes that it has demonstrated the efficacy and safety of its once-daily tramadol formulation.
Based on data from the Company's global clinical trial program submitted with the NDA, including a positive Phase III study conducted in accordance with a Special Protocol Assessment, Labopharm strongly believes that it has provided the FDA with more than adequate evidence of the efficacy and safety of its once-daily formulation of tramadol.
Should Labopharm and the Agency fail to mutually agree on a path forward toward final regulatory approval, or should the FDA not grant the meeting within the next 30 days, Labopharm plans to appeal the FDA's current decision through the Agency's Formal Dispute Resolution process.
Labopharm's NDA for once-daily tramadol included data from the Company's global clinical development program including six Phase III clinical studies and 12 pharmacokinetic studies. Combined, more than 2400 patients have been exposed to Labopharm's once-daily tramadol in clinical studies.
About the FDA's Formal Dispute Resolution Process
FDA regulations provide a mechanism for those seeking regulatory
approval of a drug product through a New Drug Application (NDA) to obtain
formal review of any Agency decision through a Formal Dispute Resolution
process by raising the matter with the supervisor of the employee who made
the decision. If the issue is not resolved at the primar
|SOURCE Labopharm Inc.|
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