Cannabis-Based Drug Receives First European Market Approvals for Chronic Back Pain

After more than a decade in development, a full-spectrum cannabis extract has received market authorisation in Germany and Austria, with UK approval expected by the end of the year.

Developed by German biopharmaceutical company Vertanical, Exilby® (also known as VER-01) will now be prescribed for the treatment of chronic lower back pain with a neuropathic component. It is expected to be eligible for reimbursement in line with national processes.

This approval comes following two randomised, controlled Phase 3 trials completed last year, in which the drug was found to reduce pain more effectively than opioids and with significantly greater tolerability.

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A New Class of Treatment for Chronic Pain

Chronic pain remains one of the largest unmet needs in healthcare, affecting more than one billion people worldwide. Despite its major medical, social, and economic burden, innovation in treatment has substantially lagged behind other major disease areas. Many patients remain reliant on opioids despite well-documented risks and side effects.

Vertanical’s founder, Dr Clemens Fischer, has invested more than $250 million of his own fortune into developing Exilby to address what he sees as one of the largest unresolved challenges in medicine.

"His view was that a rigorously developed, standardised cannabinoid-based medicine, supported by Phase 3 clinical evidence, could represent a genuinely new class of treatment for chronic pain," a representative for the company told Cannabis Health.

In clinical trials completed last year:

• The drug demonstrated significant reductions in pain compared with placebo.
• Patients experienced measurable improvements in sleep quality and physical function.
• A second, Phase 3 comparator study demonstrated greater pain reduction and better gastrointestinal tolerability compared with standard opioids.
• Across the clinical program, VER-01 was generally well tolerated, with no evidence of dependence or withdrawal symptoms observed.

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NICE and UK MHRA Timelines

Vertanical says it is now preparing a submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for later this year, with marketing authorisation targeted before the end of 2026.

According to the company, it has already been identified by the National Institute for Health and Care Excellence (NICE) health technology assessment pathway as a treatment that should undergo clinical and economic evaluation, moving it closer toward NHS availability.

Professor Roger Knaggs, Professor of Pain Management at the University of Nottingham and President of the British Pain Society, commented:

"Chronic low back pain with a neuropathic component is particularly difficult to treat and remains a major burden for too many patients in the UK. The marketing authorization of Exilby® in Germany and Austria signals that meaningful innovation in chronic pain is possible. For patients with a neuropathic pain component, Exilby may represent an important breakthrough."

The drug has also been granted Breakthrough Therapy Designation from the FDA, with clinical trials now expected to get underway in the US.