Why It Matters

The study was picked up by AP, among other major news outlets, including New Scientist. If tens of thousands of studies are published on cannabis every year, why did this one hit the headlines?

While previous research has pointed to the potential pain-relieving effects of cannabis, the majority of these studies are small, early-stage, or observational.

Vertanical’s trials involved a large patient sample, a randomized design, and direct comparison with opioids, factors which are widely regarded as the gold standard of scientific research when testing safety and efficacy.

Phase III trials are the final stage of the research process before a new drug can be submitted for regulatory approval.

Vertanical says it has submitted applications for marketing authorization in several European countries, and a Phase III study in the U.S is planned to start in early 2026 to support FDA approval.

“Patients and physicians have long sought novel treatments for chronic pain,” Prof. Roger Knaggs, Professor of Pain Management and President of the British Pain Society said in a statement.

“If approved, VER-01 could represent the first new class of chronic pain medicine for a very long time.”

Transforming How We Treat Pain

In the U.S. alone, over 2.1 million people are thought to have opioid use disorder linked to prescription opioids, with more than 60 million people thought to struggle with opioid addiction or dependence globally.

As a result of the overprescribing of opioids, which led to an epidemic contributing to approximately 800,000 opioid-related deaths in the U.S. between 1999 and 2023, these medications are no longer recommended for chronic pain. And over-the-counter pain relievers like ibuprofen aren’t safe for long-term use. For the billions of people living with long-term pain, treatment options are limited.

This is not the first time cannabis has been touted as a potential alternative, but it is the first time such an advanced scientific study has shown it to be an effective one.

Professor Charles E. Argoff, Professor of Neurology at Albany Medical College and Past President of the American Academy of Pain Medicine said in a statement that the new findings provide “powerful evidence” that if approved VER-01 could “transform how we care for patients with chronic lower back pain”.

“The results of the Phase 3 studies bring hope to millions living with chronic pain that, if approved, VER-01 could deliver effective pain relief while addressing key safety challenges of current therapies,” he said.

A Safer Alternative

Dr Ari Greis, board member of the Rothman Opioid Foundation and Director of Medical Cannabis at Rothman Orthopaedics, agreed over email that this new drug and “similar” cannabis-based medicines may be a “safer alternative” to NSAIDs and opioids.

“This study highlights the potential of pharmaceutical-grade cannabis products in the management of chronic pain,” he said.

“I believe that the effectiveness of cannabis-based products has been shown to help with chronic pain as well as, if not better than, opioids and NSAIDs, with significantly less risk of harm.

“This drug, and similar cannabis-based drugs available in medical cannabis dispensaries across the country, may be a safer alternative to NSAIDs and opioids, particularly for chronic pain that requires long-term treatment.”

While Vertanical’s study focused specifically on chronic lower back pain, Dr Greis believes the results are “likely applicable to other types of orthopedic pain”. He says low-dose cannabis products should be considered as part of a “multimodal pain management plan” and healthcare professionals should provide guidance for patients around these.

“For the past seven years, I have personally witnessed patients with chronic orthopedic pain transition from opioids to a combination of oral and topical THC and CBD,” Greis added.

“For many patients, cannabis offers an alternative to other pain medications that often cause significant side effects and come with potential risks.”