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Introduction <p>Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives.</p> Methods <p>This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from <i> Cannabis sativa</i> DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24&#xa0;weeks of treatment, followed by 2&#xa0;weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27&#xa0;weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27.</p> Results <p>A total of 384 individuals were randomized to receive VER-01 (<i>n</i> = 192) or opioids (<i>n</i> = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95% confidence interval [CI] 0.09–0.69; <i>p</i> = 0.007) and threefold less likely to use laxatives (RR 0.34; 95% CI 0.18–0.65; <i>p</i> &lt; 0.001). Longitudinal analysis revealed that VER-01 was superior to opioids in terms of pain reduction over 6&#xa0;months of treatment, although differences in secondary endpoints limited to week 27 alone were not significant. Throughout the 6&#xa0;months of treatment, mean pain reduction was 2.50 NRS points with VER-01 versus 2.16 with opioids (mean difference [MD] 0.34; 95% CI 0.00–0.67; <i>p</i> = 0.048), and sleep improved by 2.52 points with VER-01 versus 2.07 with opioids (MD 0.45; 95% CI 0.11–0.79; <i>p</i> = 0.009). These benefits were particularly pronounced in participants with severe pain, with greater pain reduction (MD 0.58; 95% CI 0.01–1.15) and sleep improvement (MD 0.66, 95% CI 0.05–1.27) compared to opioids.</p> Conclusions <p>VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.</p> Trial Registration <p>ClinicalTrials.gov ID: NCT05610813; EudraCT ID: 2022-001358-41.</p>

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VER-01 Shows Enhanced Gastrointestinal Tolerability, Superior Pain Relief, and Improved Sleep Quality Compared to Opioids in Treating Chronic Low Back Pain: A Randomized Phase 3 Clinical Trial

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  • 发表日期：

    2025年9月30日

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  • Winfried Meissner,
  • Charles Argoff,
  • Sabine Sator,
  • Volker Schoder,
  • Matthias Karst

摘要

Introduction

Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives.

Methods

This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from Cannabis sativa DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24 weeks of treatment, followed by 2 weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27 weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27.

Results

A total of 384 individuals were randomized to receive VER-01 (n = 192) or opioids (n = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95% confidence interval [CI] 0.09–0.69; p = 0.007) and threefold less likely to use laxatives (RR 0.34; 95% CI 0.18–0.65; p < 0.001). Longitudinal analysis revealed that VER-01 was superior to opioids in terms of pain reduction over 6 months of treatment, although differences in secondary endpoints limited to week 27 alone were not significant. Throughout the 6 months of treatment, mean pain reduction was 2.50 NRS points with VER-01 versus 2.16 with opioids (mean difference [MD] 0.34; 95% CI 0.00–0.67; p = 0.048), and sleep improved by 2.52 points with VER-01 versus 2.07 with opioids (MD 0.45; 95% CI 0.11–0.79; p = 0.009). These benefits were particularly pronounced in participants with severe pain, with greater pain reduction (MD 0.58; 95% CI 0.01–1.15) and sleep improvement (MD 0.66, 95% CI 0.05–1.27) compared to opioids.

Conclusions

VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.

Trial Registration

ClinicalTrials.gov ID: NCT05610813; EudraCT ID: 2022-001358-41.