DOV PHARMACEUTICAL INITIATES PHASE III ANALGESIC TRIAL

DOV Pharmaceutical announced it has initiated a Phase III clinical trial of bicifadine, its novel analgesic, in the treatment of postoperative pain following vaginal hysterectomy.

The clinical trial is a randomized, multicenter (20-30 sites), parallel, placebo controlled trial with 100 patients per treatment arm (bicifadine 400 mg or placebo). Study medication will be administered for up to five days in patients who experience moderate-to-severe pain following surgery. The primary efficacy endpoints are the patients' assessment of pain intensity using a categorical scale and pain relief based on changes in pain intensity using a visual analog scale of pain ratings.

Bicifadine is a chemically novel molecule with a unique profile of pharmacological activity. In regard to mechanism of action it is a balanced SNRI (serotonin and norepinephrine reuptake inhibitor) and is not an opiate nor NSAID (nonsteroidal anti-inflammatory drug) nor a COX-2 inhibitor. In animal models, bicifadine does not demonstrate any significant abuse liability, addiction or dependence potential.