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FDA Grants Breakthrough Therapy Designation to Cannabis-Derived Drug for Chronic Back Pain

The U.S. Food and Drug Administration (FDA) last month granted Breakthrough Therapy Designation to VER-01, a cannabis-derived, full-spectrum drug for chronic low back pain produced by German company Vertanical. The designation follows two randomized, controlled Phase 3 trials, which demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence.   In a direct Phase 3 head-to-head comparator study, […]