Overview

• The multicenter, randomized, placebo-controlled study enrolled about 820 adults across 66 sites in Germany and Austria with chronic low back pain resistant to standard treatments.
• VER-01 reduced pain by a mean 1.9 points on a 0–10 scale at 12 weeks versus 0.6 with placebo, with average reductions around 2.9 points at later follow-up and more than 54% achieving at least a 30% decrease.
• A withdrawal substudy found no abstinence syndrome when the drug was replaced with placebo, although pain increased after discontinuation, indicating no observed dependence.
• Early side effects were common—dizziness in 43%, nausea and headaches in 16% each—and 17% discontinued within 12 weeks, while remaining participants reported better sleep, mobility and quality of life.
• The oral extract is standardized per dose to 2.5 mg THC, 0.1 mg cannabigerol and 0.02 mg cannabidiol, and Vertanical says it has applied for EU marketing authorization with approvals anticipated in 2026.