Back pain is one of the most frustrating medical problems: ubiquitous, persistent, and often poorly served by existing therapies. That’s what makes Vertanical’s newly reported data so compelling. The company’s cannabis-derived drug, VER-01, appears to reduce chronic low back pain meaningfully — and without triggering the kind of risks that bedevil opioid therapies.

What the study shows

In a large, placebo-controlled, phase 3 trial involving around 800 patients, those who received VER-01 saw pain drop by nearly 2 points on an 11-point scale over 12 weeks, compared to a 1.4-point drop with placebo. AP News+2pharmaphorum+2 Encouragingly, people who continued into an extension phase maintained and even improved those gains — average reductions reached about 2.9 points over six months.

Beyond just feeling less pain, participants reported better sleep, improved physical function, and enhanced quality of life. And perhaps most importantly, there was no evidence of abuse, dependence, or withdrawal.  Side effects did occur — dizziness, nausea, fatigue, and headaches — and more than 17% of participants dropped out early. But that dropout rate is, in context, lower than what is often seen in opioid trials with their heavy side-effect burdens.

Importantly, despite containing low doses of THC — the psychoactive compound in cannabis — the drug apparently produced no “high” sensations as measured in the trial. 

Why this matters

For people with chronic low back pain, options are scarce and often problematic. Nonsteroidal anti-inflammatories can’t safely be used long term; opioids carry risks of addiction, overdose, and other side effects.  In contrast, a therapy based on a cannabis extract that delivers real, sustained pain relief — with improvements in sleep and function — might shift the paradigm.

Moreover, the trial addresses a long-standing gap in cannabis research. For years, claims of cannabis-based pain relief have outpaced rigorous evidence. This trial, published in Nature Medicine, is one of the more robust steps toward turning those claims into a clinically viable treatment. 

Still, caveats remain. As some commentators note, this is one trial; replication and extension in diverse populations will be critical. Also, while the authors didn’t find signs of dependence, long-term use beyond the study frame must be monitored. And results for this particular extract (VER-01) shouldn’t be generalized to all cannabis or CBD products — these are engineered, pharmaceutical formulations, not off-the-shelf dispensary offerings.

The regulatory path and what’s next

Vertanical has already submitted applications with European regulators, and they’re engaging with the U.S. FDA to design studies to support U.S. approval. If approved, VER-01 could become among the first cannabis-derived analgesics widely prescribed for chronic back pain.

In practical terms, success hinges on multiple factors: confirming efficacy and safety over years (not months), comparing it head-to-head with existing therapies, and establishing guidelines for use (e.g. patient selection, disclaimers about driving early in therapy). It also raises deeper questions: Could similar cannabinoid-based approaches work in other pain conditions? What dosage windows balance effect versus tolerability? And how will insurers and health systems respond to a “medical cannabis” therapy that passes through standard drug approval pathways?

Perspective and caution

I find the VER-01 results both exciting and cautiously promising. It's not every day you see a treatment that strikes a balance between efficacy and safety in a notoriously difficult disease domain. But while the trial is a breakthrough, this is not a magic bullet — at least, not yet.

For patients suffering from chronic back pain, it may offer hope. For clinicians and regulators, it presents a chance to integrate the cannabis space more rigorously into medicine. And for researchers, it underscores how much more there is to learn: about optimal formulations, mechanisms, long-term effects, and broader applications.

If I were to wager, VER-01 or its descendants will be part of the next wave of analgesics — not replacing NSAIDs or opioids overnight, but offering a third path in pain treatment. Time (and further trials) will tell whether this vision becomes reality.