The new drug application (NDA) is based on data generated by a number of studies incorporating 11 pharmacokinetic studies and five phase III clinical studies. The five phase III studies consist of two US 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 Howard-Tripp, president and CEO of Labopharm. “Although previously the FDA had indicated that our submission would require an additional positive phase III study, that is no longer the case.”
Since reporting the results of its US 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.
The action date under the Prescription Drug User Fee Act for Labopharm’s NDA is September 28, 2006.