Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

Summary

Randomized, open-label, parallel-group phase III trial to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in patients with chronic non-specific low back pain for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

Timeline

Start

2023-06-08

Primary completion

2024-10-18

Completion

2024-10-18

Outcome

Met primary endpoint

paper 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) PMID 41028525 ↗

Publications

• Meissner W, Argoff C, Sator S, Schoder V, Karst M. 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. Pain Ther. 2025 Dec;14(6):1765-1782. doi: 10.1007/s40122-025-00773-z. Epub 2025 Sep 30.

Drugs

Indications

No indication recorded.