New data is now available from two Phase 3 clinical trials for VER-01, an experimental cannabis-derived drug, indicating that the drug could be safer and more effective than placebo and opioids for treating chronic low-back pain.
In a randomized, Phase 3, double-blind trial of 820 patients with chronic low-back pain, improvements were seen with VER-01 compared with a placebo after 12 weeks and were sustained over 12 months of treatment. The VER-01 group reported a nearly 3-point decrease in pain on a 10-point scale. The VER-01 group also saw an improvement in pain-related sleep disturbances along with patients’ physical function and quality of life
A separate, randomized controlled Phase 3 trial compared VER-01 with opioids in 384 patients with chronic low-back pain. VER-01 was found to be superior to opioids in terms of pain reduction over 6 months of treatment. Throughout the 6 months of treatment, mean pain reduction using an 11-point numeric rating scale (NRS) was 2.50 NRS points with VER-01, versus 2.16 with opioids.
These benefits were particularly pronounced in participants with severe pain, with greater pain reduction and sleep improvement compared to opioids. Furthermore, patients receiving VER-01 were four times less likely to develop constipation.
