People with chronic bad backs may soon have cause to jump for joy—carefully, of course. A large-scale, randomized, double-blinded, and controlled clinical trial has shown that a specifically formulated cannabis extract can significantly alleviate people’s back pain.
German-based pharmaceutical company Vertanical developed the extract, code-named VER-01, and sponsored the phase III trial. People who took VER-01 experienced a greater reduction in pain compared to people on a placebo, the study researchers found. The company has already filed for regulatory approval of its drug in Europe and is planning to secure approval from the U.S. Food and Drug Administration as well.
Robust evidence
The trial, conducted in several different phases, involved over 800 adults diagnosed with chronic low back pain. In the first phase, roughly half the participants were randomized to receive VER-01 (taken orally daily), while the other half received a control substance. The researchers then tracked the participants over a 12-week period.
By the end of the 12 weeks, the VER-01 group showed a statistically significant improvement in pain over the placebo group.
On an 11-point scale commonly used to assess pain, people taking VER-01 saw a 1.9-point drop on average, for instance, compared to the average 1.4-point drop seen in the placebo group. People who continued taking the drug after the first phase experienced greater pain reduction over time as well. And those on VER-01 also reported greater improvement in their sleep quality and physical functioning, while the drug appeared to be safely tolerated, with no signs of dependence or withdrawal.
“In conclusion, this phase 3 study provides robust evidence supporting the efficacy and safety of VER-01 in the treatment of [chronic low back pain],” the authors wrote in their paper, published Monday in Nature Medicine.
Outside experts appear to be excited about the drug’s potential as well.
“This is an excellent study. We have long argued that studies on cannabis or cannabis-based substances need to provide high level of evidence: this is it,” Jan Vollert, a lecturer in Neuroscience at the University of Exeter in the UK, told the Science Media Center. “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.”
The future of VER-01
Many studies have suggested that cannabinoids, the primary compounds found in cannabis, can help treat pain. Countries in Europe and Asia have also licensed specific formulations of cannabis to treat nerve pain. Yet other research has failed to show a consistent painkilling effect from cannabis.
Some of this mixed evidence might be due to the fact that cannabis comes in many different strains, each with a different variety or proportion of these compounds. Vertanical and its researchers argue that its extract has the right mix of cannabinoids and other ingredients to reliably provide pain relief. Notably, the extract only contains 5% THC. Though THC is the ingredient responsible for the “high” of cannabis, the level found in VER-01 is lower than what’s typically found in recreational products or strains available today (often reaching 15% or higher).
The pain reduction documented in this latest study is relatively modest. But given the lack of other effective non-opioid options for back pain, VER-01 could certainly become a widely used alternative treatment, one without the potential for harmful addiction. It’s estimated that about 40% of adults in the U.S. have had back pain in the last three months, while more than 10% of Americans may currently have chronic back pain.
Following the initial release of its Phase III data earlier this year, Vertanical has already submitted for VER-01’s approval in Europe; it’s planning to file for approval in the UK as well. The company is also in talks with the FDA to design a study that, if successful, could convince the U.S. regulator to grant approval.
Source: gizmodo.com
