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VER-01 Eases Chronic Back Pain in Phase 3 Study as German Regulator Weighs Approval

German authorities are reviewing the cannabis extract after a peer-reviewed trial reported modest benefits with no signs of dependence.

Overview

  • A Nature Medicine–published phase 3 study in 820 adults found VER-01 reduced pain by 1.9 points on a 0–10 scale over 12 weeks versus a 1.4-point drop with placebo.
  • Participants also reported better sleep and improved physical well-being compared with baseline.
  • The treatment was generally well tolerated, with early dizziness, somnolence and nausea most common, and no observed dose escalation, abuse, dependence or withdrawal.
  • Experts called the findings clinically relevant but not a paradigm shift, noting potential greater benefit for patients with neuropathic pain features requires further confirmation.
  • Germany’s BfArM is evaluating an approval application, and the product could reach the market this year under the brand name Exilby if cleared.