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"Vertanical Secures FDA Breakthrough Designation for Cannabis-Based Pain Drug" "The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to VER-01, the flagship full-spectrum cannabis drug from Munich-based Vertanical, putting it in prime position to become the first FDA-approved cannabis-derived medicine for pain, and only the second such approval since Epidiolex in 2018." "VER-01’s designation follows two Phase 3 randomised controlled trials (RCTs).  In a placebo-controlled study of 820 patients published in Nature Medicine in September 2025, VER-01 met its primary endpoint with effects sustained over the long term and significant improvements in sleep and physical function. A second head-to-head comparator study, the ELEVATE trial, across 384 patients in Germany, the Czech Republic, Poland and Spain, found VER-01 delivered superior pain reduction and better gastrointestinal tolerability compared with opioids, with no evidence of dependence or withdrawal."