VERTANICAL has received marketing authorisation in Germany for Exilby, a non-opioid treatment for chronic low back pain with a neuropathic component. The approval marks the first European authorisation for what the company describes as a first-in-class therapy. The authorisation follows two Phase 3 trials involving over 1,200 patients, which demonstrated significant pain reduction and favourable tolerability with no evidence of dependence. A head-to-head comparator study showed Exilby delivered superior pain reduction and better gastrointestinal tolerability than opioids. Exilby is a standardised cannabis extract derived from a proprietary Cannabis sativa strain. Whilst not yet approved in the US, VERTANICAL has initiated a pivotal US Phase 3 trial, with data expected in 2027. The FDA has granted Breakthrough Therapy Designation. The company plans to submit a New Drug Application in 2028.