Nat Med
Cannabis extract shows promise for chronic low back pain in phase 3 trial
VER-01, a full-spectrum Cannabis sativa DKJ127 extract, shows promise as a safe, nonaddictive alternative to opioids and NSAIDs for chronic low back pain (CLBP), offering sustained pain relief and functional benefits. Its standardized formulation may support regulatory approval and clinical adoption.
Study details: This multicenter, randomized, placebo-controlled phase 3 trial (NCT04940741) evaluated VER-01 in 820 adults with CLBP. Participants underwent a 12-week double-blind treatment phase (A), a 6-month open-label extension (B), and either a continuation (C) or randomized withdrawal (D). Primary endpoints included changes in numeric rating scale (NRS) pain intensity and neuropathic pain symptom inventory (NPSI) scores.
Results: VER-01 met its primary endpoint in phase A, reducing mean NRS pain scores by −1.9 points (mean difference [MD] vs. placebo, −0.6; 95% confidence interval [CI], −0.9 to −0.3; P < 0.001), with further reduction to −2.9 points in phase B and sustained effects through phase C. NPSI scores improved significantly (−14.4 points; MD vs. placebo, −7.3; 95% CI, −13.2 to −1.3; P = 0.017). Although phase D didn’t meet its primary endpoint, pain worsened more with placebo upon withdrawal (P = 0.034). Adverse events were more frequent with VER-01 (83.3% vs. 67.3%) but were mostly mild and transient. No signs of dependence or withdrawal were observed.
Source:
Karst M, et al. (2025, September 29). Nat Med. Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. https://pubmed.ncbi.nlm.nih.gov/41023483/