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Phase 3 Results of Bicifadine in Low Back Pain Disappointing

HACKENSACK, N.J., April 24 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced today high-level results recently developed from the first Phase III placebo-controlled clinical trial -- study 020 -- of its novel analgesic bicifadine in patients with chronic low back pain (CLBP). 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 b.i.d. The primary endpoint as defined in the study protocol was the improvement in Visual Analog Scale (VAS) pain scores between baseline and the end of the treatment period. Initial analysis points to an unusually high placebo response rate and the extent of patients' reliability in taking their medication as potential factors in the study outcome. The trial was a U.S., multi-center, double-blind, placebo-controlled study of approximately 600 patients with CLBP who were treated for up to 12 weeks.

DOV is currently conducting a more detailed assessment of the trial data in order to better understand the factors which are responsible for these findings.

"We are disappointed by the unexpected results of our Phase III trial, study 020," said Dr. Leslie Hudson, President and Chief Executive Officer of DOV. "We are continuing forward with our Phase II trials of bicifadine in osteoarthritis and neuropathic pain and our two Phase III 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: DOV Pharmaceutical

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