HealthDay News — A novel cannabinoid formulation, nabiximols, is safe and effective for patients with advanced cancer and opioid-refractory pain, especially at a low-dose, study findings suggest.

Russell K. Portenoy, MD, of the Beth Israel Medical Center in New York City, and associates conducted a randomized, double-blind, placebo-controlled, graded-dose study involving 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.

Compared with placebo, the 30% responder rate primary analysis was not significant for nabiximols (P = 0.59).

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However, 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), the reserachers reported in the Journal of Pain.

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 researchers wrote. “Confirmatory studies are strongly warranted.”

The study was funded by nabiximols manufacturer GW Pharmaceuticals.

Portenoy RK et al. J Pain. 2012; 13(5):438-449.