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.

ABSTRACT:

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 (27 mg/mL): cannabidiol (25 mg/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-we

SUBMITTER: Fallon MT 

PROVIDER: S-EPMC5521351 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature