A double-blind, randomized, placebo-controlled, parallel group study of THCCBD spray in peripheral neuropathic pain treatment.
Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinolcannabidiol (THCCBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study. In total, 303 patients with PNP associated with allodynia were screened 128 were randomized to THCCBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. At the 30% responder level, there were statistically significant treatment differences in favour of THCCBD spray in the full analysis (intention-to-treat) dataset p 0.034 95% confidence interval (CI) 1.05-3.70. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THCCBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p 0.0072) and Subject Global Impression of Change (SGIC) (p 0.023) also demonstrated statistically significant treatment differences in favour of THCCBD spray treatment. These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THCCBD spray. THCCBD spray was well tolerated and no new safety concerns were identified.