First European approval given to non-opioid treatment for chronic low back pain
pharmafile | June 9, 2026 | News story | Research and Development |Â Â low back pain, non-opioid treatmentÂ
Germany has granted marketing authorisation to Exilby (VER-01) for the treatment of chronic low back pain with a neuropathic component, marking the first European approval for the therapy.
The decision follows results from two phase 3 studies that evaluated the treatment in patients with chronic pain. According to VERTANICAL, the trials demonstrated significant reductions in pain, a favourable tolerability profile and no evidence of dependence.
In a head-to-head phase 3 study, VER-01 was also reported to provide greater pain reduction and better gastrointestinal tolerability than opioid treatment.
Chronic pain affects more than one billion people worldwide, including an estimated 28 million adults in the UK. Despite the burden of disease, treatment options remain limited and many patients continue to rely on opioid medicines, which can be associated with dependence and other adverse effects.
In a placebo-controlled phase 3 study, VER-01 met its primary endpoint and demonstrated sustained pain reduction during longer-term treatment. Patients also reported improvements in sleep disturbance and physical functioning.
Dr Stuart Ratcliffe, Chief Scientific Officer at St Pancras Clinical Research and a principal investigator in one of the trials, said chronic low back pain with a neuropathic component remained particularly difficult to treat and represented a substantial burden for patients.
VERTANICAL is preparing a submission to the Medicines and Healthcare products Regulatory Agency (MHRA), with UK marketing authorisation targeted before the end of 2026. The company said NICE has already completed topic selection as part of the health technology assessment process.
The therapy is derived from a standardised full-spectrum extract of Cannabis sativa and is intended as a non-opioid option for chronic pain management.
