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.

While marijuana remains federally illegal, medical marijuana programs operate in 40 states, and a significant barrier to utilizing marijuana more broadly in care comes from a lack of clinical data. However, drugs derived from marijuana have previously seen FDA approval, and this drug could see future approval, or at the very least spur further clinical trials for similar drugs.

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.