DOV completes enrollment in its phase 3 clinical trial of bicifadine for back pain

By Lisa Kerner

Erie, Pa., Feb. 2 - DOV Pharmaceutical, Inc. completed enrollment in its first pivotal phase 3 clinical trial (study 020) of bicifadine, its novel analgesic, for chronic low back pain, according to a company news release.

The multi-center, double-blind study compares three dose regimens of bicifadine (200, 300, 400 mg) to a placebo administered for three months to patients with chronic low back pain.

The company said it anticipates results from the trial in the second quarter of 2006.

DOV expects to accumulate all required safety data from its phase 3 open label long-term safety and efficacy trial (study 022) on schedule for a New Drug Application filing for chronic low back pain in the first half of 2007.

DOV, based in Hackensack, N.J., is a biopharmaceutical company.

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