Dov Pharmaceuticals has released new data on its recently failed trial of its pain medicine bicifadine. Dov announced last month that its lead drug candidate had proved ineffective in a pivotal trial after recording an unusually high placebo response. On Monday, researchers said the drug was effective in two significant patient groups. One group included patients with sciatica, a condition that occurs when lower back pain travels down a person's leg. The second group had moderate to severe disability due to back pain. Dov says it will continue its Phase III trial, but only admit more patients who fit in the subgroups.
"While we are surprised and disappointed by the trial failure, we are encouraged by the effect of bicifadine in the two major subgroups of study 020 patients," said Dr. Warren Stern, senior vice president of drug development at DOV. "In patients with sciatica and more life-altering chronic low back pain--those that understandably may be less responsive to placebo--bicifadine appears to have appreciable efficacy.
- here's the AP report on the data