VERTANICAL has received marketing authorization in Germany for Exilby (VER-01), a non-opioid treatment for chronic low back pain.
The approval follows two pivotal Phase 3 randomized controlled trials involving more than 1,200 patients, which demonstrated significant pain reduction, a favourable tolerability profile, and no evidence of dependence.
In a separate head-to-head Phase 3 study, Exilby outperformed opioids in reducing pain while also showing better gastrointestinal tolerability, positioning it as a potential alternative to traditional opioid therapies.
The company highlighted that chronic pain remains one of the largest unmet needs in healthcare, affecting more than one billion people worldwide. Despite its significant medical, social, and economic burden, innovation in chronic pain treatment has lagged behind other major disease areas.
While opioids continue to play a central role in pain management for many patients, the company raised concerns about their well-documented risks, including dependence, abuse potential, and debilitating side effects.
“For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk,” Dr. Clemens Fischer, CEO of FUTRUE Group and Founder of VERTANICAL.
“The German marketing authorization of Exilby shows that a different path is possible,” he added, noting that the treatment could help change the way chronic pain is managed by providing patients and physicians with an alternative to opioids.
Exilby has not yet been approved in the United States. VERTANICAL has already launched an additional pivotal Phase 3 study in the US to support a future FDA submission. The company expects the first data readout in 2027 and, pending positive results, plans to file a New Drug Application in 2028.
The US Food and Drug Administration has granted Exilby Breakthrough Therapy Designation, reflecting its potential to significantly improve treatment options in chronic pain management.
“Our focus now is to move with urgency to bring this innovation to patients in the United States,” Dr. Fischer said.
Prof. Charles E. Argoff, Professor of Neurology at Albany Medical College and Past President of the American Academy of Pain Medicine, said the European authorization and positive Phase 3 data suggest Exilby could represent the beginning of a new era in chronic pain treatment.
Exilby is a standardized full-spectrum extract derived from the Cannabis sativa strain DKJ127 L. It contains a defined mixture of cannabinoids, terpenes, and other bioactive compounds selected for their potential relevance in pain modulation and associated symptoms. The company said the product has been characterized using advanced chromatographic and spectrometric methods to ensure pharmaceutical-grade quality and consistency.
