The results of a phase 3 trial of Vertanical’s cannabis-derived therapy VER-01 for chronic lower back pain have been published, and bode well for the ongoing reviews of marketing applications for the drug.
Published in the journal Nature Medicine, the results suggest that VER-01 can provide relief for CLBP, without serious side effects or a risk of addiction. That means it could provide an effective alternative to opioid analgesics, which pose serious risks on both those fronts.
In the 820-subject trial, those taking VER-01 saw an average 1.9-point reduction in pain scores on an 11-point scale, compared to a 1.4-point reduction with placebo, at 12 weeks. The reduction in pain was accompanied by “distinct improvements in physical function and sleep quality, two key factors that contribute to participants perceiving the effects of VER-01 as clinically meaningful,” according to the study authors.
Patients who continued with a six-month extension phase continued to experience reductions in pain, with an average 2.9-point improvement.
VER-01 is a liquid cannabis extract that includes the full range of cannabinoid compounds, including low levels of tetrahydrocannabinol (THC), the main psychoactive component.
The scientists behind the study said that one limitation is the lack of a comparison with opioids, but they noted that a head-to-head trial has already been carried out and will be published separately.
Prof David Nutt of Imperial College London, an expert in neuropsychopharmacology who was not involved in the study, said that its design was “elegant” and “confirms…that whole plant extract cannabis-based products have a role in chronic pain treatment.”
A similar sentiment was expressed by Dr Jan Vollert, a lecturer in neuroscience at the University of Exeter, who said it was “an excellent study,” adding: “It is only one trial, and we will need further studies to confirm the findings, but this is a good signal that the compound could help patients. Previous studies have found mixed results with other compounds, and most were not of great quality, so this is a very clear step in the right direction.”
The level of pain relief seen with VER-01 would be significant and clinically meaningful to people living with chronic pain, continued Vollert, who also stressed that in no way does the study suggest that smoking cannabis could have the same effect.
“To me, this study does not make a case for smoking cannabis, as smoking cannabis and taking VER-01 are probably as similar as eating hazelnuts and eating Nutella: they might share a similar basis, but they just are not comparable.”
Vertanical, which revealed top-line results from the trial earlier this year, has filed for approval of its drug with European regulators, including in Germany and Austria, and has said it is in discussions with the FDA about a possible application in the US.
