Europe authorizes the first cannabis-derived medicine for the treatment of chronic pain

German biopharmaceutical company Vertanical, which we reported on last Friday after receiving «breakthrough therapy» status from the FDA for its pain relief treatment, has obtained European marketing authorization for the same treatment, the’Exilby® (VER-01), a first-in-class non-opioid treatment for chronic low back pain with a neuropathic (radicular) component.

First EU marketing authorization for chronic low back pain

This marks the first European marketing authorization for a standardized cannabis-derived treatment developed specifically for chronic pain conditions. According to the company, this treatment fills a long-standing therapeutic gap in the field of chronic low back pain, a condition that affects hundreds of millions of people worldwide, and which is often managed with limited options, especially opioids.

This authorization follows two randomized Phase 3 pivotal trials involving over 1,200 patients. These studies are said to have demonstrated significant pain reduction, a favorable safety profile and no signs of dependence, a key differentiator in a therapeutic area historically associated with opioid dependence.

In a head-to-head Phase III comparative study, Exilby® also demonstrated superior pain reduction and better gastrointestinal tolerance than opioids.

Dr Clemens Fischer, CEO of the FUTRUE Group and founder of VERTANICAL, described the approval as more than just a regulatory milestone:

«Today's approval of Exilby® in Germany is much more than a regulatory milestone for our company. It shows that significant therapeutic innovation in the field of chronic pain is possible.»

Medical experts also commented on the potential paradigm shift. Professor Charles E. Argoff, neurologist and former president of the American Academy of Pain Medicine, noted:

«The European marketing authorization and Phase 3 data suggest that Exilby® could mark the start of a new era in the treatment of chronic pain.»

Exilby® is a full-spectrum standardized extract derived from the Jack Herer variety (patented DKJ127). The oral formulation based on sesame oil contains 5% of THC, and each dose delivers 2.5 milligrams of THC, 0.1 mg of cannabigerol and 0.02 mg of cannabidiol. It is accompanied by the flower's natural terpenes, notably β-caryophyllene and α-bisabolol.

VERTANICAL also stresses that the results obtained with Exilby® cannot be extrapolated to other cannabis-based extracts, underlining the specificity of its exclusive formulation.

«FDA Breakthrough Therapy

Although Exilby® is not yet approved in the U.S., Vertanical has launched a pivotal Phase 3 clinical trial with a view to a future submission to the U.S. Food and Drug Administration (FDA). A first reading of the data is expected in 2027, with a marketing authorization application planned for 2028 if the results remain positive.

The program also received the Breakthrough Therapy Designation from the FDA, This status is reserved for treatments likely to offer a substantial improvement over existing options for the treatment of serious pathologies.