DOV Non-Opioid Bicifadine Starts Pivotal Trials In Chronic And Acute Pain
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
DOV Pharmaceutical has initiated two Phase III trials for its non-opioid analgesic bicifadine to support planned NDA filings in acute and chronic pain.
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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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