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DOV drug flops in back-pain trial
HACKENSACK, N.J., April 24 (UPI) -- DOV Pharmaceutical said Monday 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 3 study involving 600 patients with chronic lower back pain (CLBP) at multiple U.S. sites.
DOV said bicifadine "did not achieve a statistically significant effect relative to placebo on the primary endpoint of the study at any of the doses tested: 200 mg, 300 mg or 400 mg (twice daily)."
The study's primary endpoint was measured as improvement in Visual Analog Scale pain scores between baseline and the end of the treatment period, the company said.
DOV noted the trial's lackluster results could be due to "an unusually high placebo response rate and the extent of patients' reliability in taking their medication," but added it is assessing the data to pinpoint what went wrong.
"We are disappointed by the unexpected results of our phase 3 trial, study 020," said Leslie Hudson, president and chief executive officer of DOV. "We are continuing forward with our Phase 2 trials of bicifadine in osteoarthritis and neuropathic pain and our two Phase 3 trials of bicifadine in CLBP, studies 021 and 022. We will provide more detailed guidance regarding our bicifadine chronic pain program once we are in a position to do so."
Source: http://www.upi.com