DOV Pharmaceutical, Inc. has initiated a phase III US clinical trial of bicifadine, its novel analgesic, in the treatment of post-operative pain following vaginal hysterectomy.

The clinical trial is a randomized, multi-centre (20-30 sites), parallel, placebo controlled trial with 100 patients per treatment arm (bicifadine 400 mg tid 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. Secondary endpoints include, among others, time to onset of pain relief, use of analgesic rescue medication and the patient's global evaluation. These primary and secondary efficacy endpoints are widely recognized measures of analgesic efficacy. The clinical trial is one of four pivotal studies required by the FDA to support an NDA filing for an acute pain indication, said a release from DOV.

Dr. Warren Stern, DOV's Senior Vice President of Drug Development, said, "This clinical trial provides another informative model for evaluating the safety and efficacy of bicifadine in the management of acute pain. Other ongoing phase III clinical trials for bicifadine include double-blind placebo controlled evaluations of several bicifadine dosing regimens in patients with pain following bunionectomy surgery and in patients with chronic lower back pain. Also ongoing, is a phase III long-term open label clinical trial study in patients with chronic lower back pain, a trial that utilizes standard of care as a control treatment."

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.

Bicifadine has also demonstrated statistically significant analgesic effects in two placebo controlled clinical trials in patients with pain following third molar dental surgery.