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DOV bicifadine pain NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

DOV expects to submit a bicifadine NDA in 2006 for treatment of acute and chronic pain, the firm says April 1. Based on a March 30 end-of-Phase II meeting with FDA, an acute pain indication will require three pivotal, multiple-dose pain models, one of which will need to be replicated. Due to concerns about off-label use, the firm will also need to submit long-term safety data from 100 patients for one year and 300 patients for six months. The firm had planned to gather this data only in support of a chronic back pain indication. For a chronic pain indication, the firm will submit two placebo-controlled, dose-response studies of three months duration. DOV plans to initiate a five-day, acute, post-surgical bunionectomy trial and a three-month chronic back pain study in the third quarter, following special protocol review meetings with FDA in the second quarter. DOV's generalized anxiety disorder agent ocinaplon remains on clinical hold; FDA informed the firm March 30 that additional time is needed for an independent hepatologist consult...
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