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
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