FDAnews
www.fdanews.com/articles/84307-dov-pharmaceutical-completes-enrollment-in-trial-of-bicifadine

DOV PHARMACEUTICAL COMPLETES ENROLLMENT IN TRIAL OF BICIFADINE

February 3, 2006

DOV Pharmaceutical announced today that it completed enrollment in its first pivotal Phase III clinical trial (study 020) of bicifadine, its novel analgesic, in chronic low back pain (CLBP). The trial is a multicenter, double-blind study comparing three dose regimens of bicifadine (200 mg, 300 mg, and 400 mg) to placebo administered for three months to patients with CLBP. The company expects to announce results from the trial in the second quarter of 2006, as planned.

DOV expects to accumulate all required safety data from its Phase III open-label long-term safety and efficacy trial on schedule for a new drug application filing for CLBP in the first half of 2007.