DOV Pharmaceuticals put its support behind its bicifadine drug for back pain yesterday, saying that an in-depth analysis of a Phase III trial – which found no difference in efficacy between the drug and placebo – had encouraged it to press on with development.
DOV’s share price plummeted on the back of the Phase III results, first reported a month ago, but the company now says subgroup analyses suggest bicifadine was better than placebo on two groups – patients with lower back pain and pain radiating down the leg (sciatica) and those with moderate-to-severe disability, which together accounted for about half the study population.
The company said it would use the findings to help select patients for a second, ongoing Phase III trial of bicifadine in lower back pain, and also press on with a Phase II study of the drug in osteoarthritis.
However, DOV said it would halt a trial in neuropathic pain and delay the start of Phase I trials that would be needed to support an application for approval. These and other cost-cutting measures will cut the firm’s burn rate for 2006 by around $9 million.
