Cannabinoid formulation benefits opioid-refractory pain
(HealthDay) -- A novel cannabinoid formulation, nabiximols, is safe and effective for patients with advanced cancer and opioid-refractory pain, especially at a low-dose, according to a study published in the May issue of The Journal of Pain.
Russell K. Portenoy, M.D., of the Beth Israel Medical Center in New York City, and associates conducted a randomized, double-blind, placebo-controlled, graded-dose study of 263 patients with advanced cancer and opioid-refractory pain. Participants were randomly allocated to receive low-, medium-, or high-dose nabiximols or placebo. During five-weeks of treatment, average pain, worst pain, and sleep disruption were measured daily; quality of life and mood were also assessed.
The researchers found that, compared with placebo, the 30 percent responder rate primary analysis was not significant for nabiximols (P = 0.59). In a secondary continuous responder analysis of average daily pain, a significantly higher proportion of patients reported analgesia in the nabiximols group than placebo (P = 0.035), specifically for low-dose and medium-dose nabiximols (P = 0.008 and 0.039, respectively). Results were similar for mean average pain, mean worst pain, and mean sleep disruption in the low-dose group (P = 0.006, 0.011, and 0.003, respectively). There were no significant group differences seen in other questionnaires. Dose-related adverse events were seen, with only the high-dose group comparing unfavorably with placebo.
"Based on the results of this dose-ranging study, nabiximols in a manageable dose range may prove to offer benefits to a very ill population with refractory pain," the authors write. "Confirmatory studies are strongly warranted."
The study was funded by GW Pharmaceuticals, which produces nabiximols, and Otsuka.
Full Text (subscription or payment may be required)
Copyright © 2012 HealthDay. All rights reserved.