Latest revision as of 11:18, 29 October 2024

Reference
Title	Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies
Topic	Cannabinoids
Author	Fallon, MT, Lux, EA, McQuade, R, Rossetti, S, Sanchez, R, Sun, W, Wright, S, Lichtman, AH, Kornyeyeva, E
Year	2017
Journal	British Journal of Pain
DOI	https://doi.org/10.1177/2049463717710042

Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.

Background: Opioids are critical for managing cancer pain, but may provide inadequate relief and/or unacceptable side effects in some cases.

Objective: To assess the analgesic efficacy of adjunctive Sativex (Δ9-tetrahydrocannabinol (27mg/mL): cannabidiol (25mg/mL)) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy.

Methods: This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design).

Results: The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00–17.95; p=0.040) that was not observed in patients <65years from the rest of the world (median treatment difference: 0.2; 95% CI: −5.00 to 7.74; p=0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified.

Conclusions: Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.

This publication is referenced in the following studies:

@@ Line 2: / Line 2: @@
 |Title=Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies
 |Topic=Cannabinoids
-|Author=Fallon, M T; Lux, E A; McQuade, R; Rossetti, S; Sanchez, R; Sun, W; Wright, S; Lichtman, A H; Kornyeyeva, E
+|Author=Fallon, MT; Lux, EA; McQuade, R; Rossetti, S; Sanchez, R; Sun, W; Wright, S; Lichtman, AH; Kornyeyeva, E
 |Year=2017
 |Journal=British Journal of Pain
@@ Line 12: / Line 12: @@
 Methods: This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design).
-Results: The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00–17.95; p=0.040) that was not observed in patients <65years from the rest of the world (median treatment difference: 0.2; 95% CI: −5.00 to 7.74; p=0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that
+Results: The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00–17.95; p=0.040) that was not observed in patients <65years from the rest of the world (median treatment difference: 0.2; 95% CI: −5.00 to 7.74; p=0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified.
-similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified.
 Conclusions: Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.
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