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Tramadol NDA Submitted for Review

LAVAL, QC, Nov. 30 /PRNewswire-FirstCall/ -- Labopharm Inc. (TSX:DDS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its once-daily formulation of the analgesic tramadol. Labopharm is seeking regulatory approval to market its once-daily tramadol for the management of moderate to moderately severe pain. The action date under the Prescription Drug User Fee Act (PDUFA) for Labopharm's NDA is September 28, 2006.

Labopharm's NDA for its once-daily formulation of tramadol is based on comprehensive data generated by a global clinical package incorporating 11 pharmacokinetic studies and five Phase III clinical studies. The five Phase III studies consist of two U.S. studies versus placebo, one European study versus an active comparator, and two long-term safety studies. Combined, almost 2000 patients were enrolled in the studies.

"During discussions with the FDA, we were informed that our existing clinical package is sufficient for our NDA to be accepted for review and considered for approval," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Although previously the FDA had indicated that our submission would require an additional positive Phase III study, that is no longer the case. Pending regulatory approval of this application, we look forward with our US marketing partner, Purdue Pharma Products, L.P. to bringing our once-daily formulation of tramadol to the US market."

As reported in January 2004, in the positive U.S. Phase III clinical trial required by the FDA for submission of the NDA (trial MDT3-003), the three co-primary endpoints achieved statistical significance, providing an improvement as measured by the change in the WOMAC Osteoarthritis Pain subscale, the WOMAC Osteoarthritis Function subscale and the patient's global assessment. Furthermore, Labopharm's once-daily tramadol provided pain relief for a full 24-hour period, and exhibited a safety profile that compared favourably with that of the Company's European Phase III clinical trial (MDT3-001) and superior to that of the immediate-release formulation of tramadol (Ultram(R)), as reported in the literature.

Since reporting the results of its U.S. Phase III trials in January 2004, Labopharm engaged in additional analysis of the MDT3-003 data. Responder analysis demonstrated that the results of the study are highly statistically significant. In addition, statistical significance demonstrated through the original analysis of the results was confirmed using multiple imputation methods.

Because Labopharm's third U.S. Phase III efficacy trial for once-daily tramadol (MDT3-005) is no longer required for the NDA, the Company elected to expand enrolment in the trial to improve the power of the study in support of marketing efforts, should the product receive marketing approval from the FDA. Enrolment for the study has been completed and the results will be reported in due course.

Source: Labopharm Inc.

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