Abstract
Patients with advanced cancer who have pain that responds poorly to opioid therapy
pose a clinical challenge. Nabiximols (Nabiximols is the US Adopted Name [USAN] for
Sativex [GW Pharma Ltd, Wiltshire, UK], which does not yet have an INN), a novel cannabinoid
formulation, is undergoing investigation as add-on therapy for this population. In
a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced
cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1–4
sprays/day), medium dose (6–10 sprays/day), or high dose (11–16 sprays/day). Average
pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment;
other questionnaires measured quality of life and mood. A total of 360 patients were
randomized; 263 completed. There were no baseline differences across groups. The 30%
responder rate primary analysis was not significant for nabiximols versus placebo
(overall P = .59). A secondary continuous responder analysis of average daily pain from baseline
to end of study demonstrated that the proportion of patients reporting analgesia was
greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain
(P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events
were dose-related and only the high-dose group compared unfavorably with placebo.
This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels
and provides important dose information for future trials.
Perspective
Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for
patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled,
graded-dose study demonstrated efficacy and safety at low and medium doses.
Key words
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Article info
Publication history
Published online: April 09, 2012
Accepted:
January 14,
2012
Received in revised form:
December 19,
2011
Received:
August 30,
2011
Footnotes
Supported in part by the Huntsman Cancer Foundation (S.W.).
GW Pharmaceuticals produces nabiximols, which is licensed in Canada as an adjunctive analgesic treatment in adult patients with advanced cancer. This study was funded by GW Pharmaceuticals and Otsuka.
Identification
Copyright
© 2012 American Pain Society. Published by Elsevier Inc. All rights reserved.
