Pharmos' IV cannabinor misses Ph IIa endpoints

US drugmaker Pharmos says that its intravenous cannabinor missed the primary endpoint defined by analgesic effects compared to placebo in a Phase IIa capsaicin-induced pain model. However, the firm noted that its CB2-selective synthetic cannabinoid confirmed the safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.

The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia and hyperalgesia. Pharmos' chief executive said that, "while we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly-developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration. 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. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising."

Pharmos recently completed preclinical toxicology and safety pharmacology studies on oral cannabinor, the data from which support initiation of Phase I testing, according to a company press statement.