Chronic pain continues to be a widespread health problem, affecting approximately 100 million people in the US and an estimated 13 to 50 percent of adults in the United Kingdom.
Not only is chronic pain a physical burden; it is costly, linked to increased healthcare expenses, and reduced productivity. It also impacts a patient's daily life, limiting activity, disrupting sleep, affecting mood, and straining social interactions.
For decades, opioids have commonly been used as first-line treatment for chronic pain, but their widespread use has fueled an epidemic. In the US alone, from 1999 to 2018, more than 750,000 people died from drug overdoses, the majority involving opioids. Increased deaths and growing concerns over addiction have prompted healthcare professionals to reevaluate the approach to chronic pain management.
In September, the FDA issued new guidelines supporting the development of non-opioid painkillers. However, the road to replacing opioids has been littered with setbacks. Several high-profile non-opioid candidates have faltered; after the FDA approved Vertex Pharmaceuticals’ first non-opioid therapy, Journavx, in January, the company soon shelved a follow-up candidate after disappointing clinical results. Acadia Pharmaceuticals also abandoned a once-promising pain therapy in 2022 after a failed trial, and Biogen discontinued vixotrigine after it failed to meet key endpoints in 2021.
Another possible basis for non-opioid therapies lies in cannabis. In March, researchers at Washington University in St. Louis and Stanford University reported that a cannabis-derived compound reduced pain in mice with minimal side effects, offering a new mechanistic insight in a field long dogged by inconsistent data and limited human studies.
Now, a Munich-based company may be on the verge of translating that potential into a market-ready medicine. Vertanical has developed VER-01, a standardized full-spectrum extract from the Cannabis sativa strain DKJ127 L. Carefully calibrated levels of cannabinoids, including THC (tetrahydrocannabinol), are designed to relieve pain without producing the psychoactive effects typically associated with cannabis, potentially offering a safer, non-addictive alternative to opioids.
Clinical proof of cannabis efficacy in pain management
Vertanical announced results from two Phase 3 clinical trials, published today in Nature Medicine and Pain & Therapy, that position VER-01 as perhaps the most advanced cannabis candidate in development for chronic pain.
In a placebo-controlled study of 820 patients with chronic low back pain, VER-01 significantly reduced pain intensity. Patients reported a 1.9-point reduction on a 0–10 pain scale after 12 weeks, which increased to 2.9 points over six months, with benefits sustained for up to a year. Participants with neuropathic pain experienced particularly pronounced improvements. Importantly, VER-01 was well tolerated, with mostly mild and transient side effects such as dizziness or fatigue, and there were no signs of dependence, abuse, or withdrawal.
In a second study, VER-01 was tested head-to-head against commonly prescribed opioids in 384 patients with chronic low back pain. VER-01 demonstrated superior pain relief, with patients reporting a 2.5-point reduction on the 0–10 pain scale, compared with a 2.16-point reduction for opioids. Additionally, the cannabis extract was found to be safer and better tolerated as patients were four times less likely to develop constipation — a common side effect of opioids — and experienced fewer gastrointestinal problems overall.
“These findings provide powerful evidence that VER-01 could transform how we care for patients with chronic low back pain,” said Charles E. Argoff of Albany Medical College in a statement, noting that the drug may provide “effective pain relief without the risks and harms associated with existing therapies.”
A new chapter for cannabis medicines?
Cannabis-based products have long been explored for chronic pain, but the field has suffered from inconsistent evidence and a lack of rigorously designed trials. VER-01 could change that.
Unlike dispensary products or artisanal extracts, Vertanical’s therapy is chemically defined, batch-consistent, and manufactured under pharmaceutical standards — qualities regulators will demand if cannabis-based medicines are to be taken seriously.
“The two landmark Phase 3 studies show that VER-01 could be a transformative therapy,” said Roger Knaggs, Professor of Pain Management at the University of Nottingham and President of the British Pain Society, in the press release. “Patients and physicians have long sought effective treatments for chronic pain. If approved, VER-01 could represent the first new class of chronic pain medicine for a very long time.”
Vertanical has filed for marketing authorization in several European countries, with decisions expected in 2026, and plans to launch a pivotal US Phase 3 trial in early 2026 to support FDA approval.
