A new treatment has emerged for chronic low back pain, which affects more than 500 million people. It is the first nonaddictive pain treatment made from cannabis components, and it showed efficacy in a phase 3 clinical trial without serious side effects.
An international research team led by Hannover Medical School announced on the 29th (local time) in the journal Nature Medicine that a new drug, "VER-01," made from components extracted from the cannabis plant, was effective in relieving pain and was safe without addiction or serious side effects, based on phase 3 clinical trial results.
Chronic low back pain is a condition in which pain in the lower back persists for more than three months and can arise for various reasons, including sedentary habits, aging, and muscle or nerve damage. It significantly interferes with daily life and is cited as a major cause of reduced quality of life and disability.
Treatment for chronic low back pain mainly relies on anti-inflammatory analgesics or opioid painkillers. However, long-term use of anti-inflammatory analgesics raises concerns about cardiovascular or gastrointestinal side effects, and opioids carry a constant risk of misuse due to strong addictiveness.
VERTANICAL, a German biotech corporations, developed VER-01, an oral treatment for chronic low back pain using components extracted from cannabis leaves and flowers. The researchers administered VER-01 to 820 patients with chronic low back pain. All had not achieved sufficient results with existing nonopioid painkillers.
Pain is self-rated on a scale from 0, meaning no pain, to 10, meaning extreme pain. In the group given VER-01, the pain score fell by an average of 1.9 points after 12 weeks. In contrast, the group given a placebo dropped by only 0.6 points.
The researchers said that in an extension study over six months, patients who received VER-01 saw their pain decrease by an additional 1.1 points. This shows not just a temporary effect but sustained pain relief.
VER-01 was relatively safe in terms of side effects. Some participants reported dizziness, drowsiness, and nausea during the initial treatment phase, but most cases were temporary, the researchers said. There were no signs of tolerance requiring dose escalation, dependence, or withdrawal symptoms. The addiction and side effects associated with opioids did not appear.
Matthias Karst, a professor at Hannover Medical School, said, "VER-01 is the first cannabis-based therapy that can reduce chronic pain without the risk of addiction," adding, "It will be a new alternative especially for countries where dependence on opioids is severe."
Jan Vollert, a professor at the University of Exeter in the U.K. who did not participate in the study, said, "I have long argued that research on cannabis or cannabis-based substances should provide high levels of evidence, and this study is exactly that example," adding, "Further studies are needed to confirm it, but the pain-relief effect is clinically meaningful."
Cannabis has a dual nature as both a narcotic and a therapy. Marijuana, which is made by drying and smoking cannabis flowers and leaves, is problematic because the tetrahydrocannabinol (THC) component causes hallucinations and addiction. By contrast, cannabis also contains cannabidiol (CBD), which has therapeutic effects such as anticonvulsant and analgesic properties, and is being developed into treatments. The U.S. Food and Drug Administration (FDA) in 2018 approved Epidiolex, a drug containing cannabis-derived CBD, as a treatment for pediatric epilepsy.
The researchers explained that VER-01 is not a single specific component but works through a complex action of multiple components. Professor Vollert emphasized, "The substance used in this study is a specific form of extract and cannot serve as a justification for smoking marijuana."
References
Nature Medicine (2025), DOI: https://doi.org/10.1038/s41591-025-03977-0