FDAnews
www.fdanews.com/articles/86311-dov-back-pain-drug-fails-to-meet-trial-endpoints

DOV BACK-PAIN DRUG FAILS TO MEET TRIAL ENDPOINTS

April 25, 2006

DOV Pharmaceutical has announced that its study-drug bicifadine failed to meet its primary endpoint in treating lower back pain.

The company said it had been testing the analgesic treatment in a 12-week, placebo-based Phase III study involving 600 patients with chronic lower back pain at multiple U.S. sites.

Bicifadine did not achieve a statistically significant effect relative to placebo on the primary endpoint of the study at any of the doses tested -- twice-daily treatments of 200 mg, 300 mg or 400 mg.