Pharmos pain trial fails to meet endpoint

The study enrolled healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin induced pain. Capsaicin is the active ingredient in chili peppers. The drug candidate did not meet the primary endpoint defined by analgesic effects compared to placebo, but confirmed safety and tolerability observed in previous studies.

Pharmos said that despite the results it has developed a new formulation of cannabinor targeting chronic neuropathic pain.

“We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a phase I safety trial in healthy volunteers,” said Dr Haim Aviv, chairman & CEO.

Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of phase I testing.

Pharmos is currently conducting a separate ongoing phase IIa clinical trial of cannabinor as a treatment for nociceptive pain. The trial is evaluating male subjects experiencing pain following third molar dental extraction. Results of this trial are expected in the first quarter of 2007.