Existing pharmacologic treatments often provide only limited relief and carry prominent risks, from gastrointestinal complications to dependency concerns. The findings from a large phase 3 clinical trial suggest that an experimental drug, VER-01, could represent a meaningful advance in treatment.
This trial enrolled 820 adults with CLBP across several international sites. The participants were randomized to receive either VER-01 (394 patients) or placebo (426 patients). The trial design included a 12-week double-blind phase (phase A), followed by a 6-month open-label extension (phase B). The patients could then either continue treatment for another 6 months (phase C) or enter a randomized withdrawal stage (phase D).
The trial met its main goal in phase A. The patients receiving VER-01 reported a mean reduction of 1.9 points on the numeric rating scale (NRS) for pain intensity, compared to a reduction of 1.3 points with placebo. This translated into a statistically significant difference of −0.6 points (95% CI, −0.9 to −0.3; P < 0.001). Also, pain relief deepened with continued use, where the average NRS pain scores dropped by 2.9 points from baseline, and these improvements were maintained through phase C.
A key secondary endpoint focused on patients with neuropathic features of back pain, identified by PainDETECT scores above 18. In this subgroup, VER-01 reduced scores on the Neuropathic Pain Symptom Inventory (NPSI) by 14.4 points, when compared with a placebo-adjusted mean difference of −7.3 (95% CI, −13.2 to −1.3; P = 0.017).
Phase D tested whether patients maintained benefit after withdrawal, did not reach statistical significance for its primary measure of treatment failure (hazard ratio = 0.75; P = 0.288). However, pain levels rose more sharply in those switched to placebo, with a mean difference of 0.5 points versus those who continued VER-01 (P = 0.034).
Side effects were more common with VER-01 than placebo in the blinded phase (83.3% vs. 67.3%). Most events were mild to moderate and short-lived. Importantly, this study observed no evidence of dependence or withdrawal symptoms, a concern with several currently available therapies for CLBP. Overall, the data suggest that VER-01 could become a new, safe, and effective option for patients with chronic low back pain, particularly those with a neuropathic component.
Source:
Karst, M., Meissner, W., Sator, S., Keßler, J., Schoder, V., & Häuser, W. (2025). Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nature Medicine, 1–8. https://doi.org/10.1038/s41591-025-03977-0
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