The U.S. Food and Drug Administration (FDA) last month granted Breakthrough Therapy Designation to VER-01, a cannabis-derived, full-spectrumย drugย for chronic low back pain produced by German companyย Vertanical. The designation follows two randomized, controlled Phase 3 trials, whichย demonstratedย significant pain reduction, a favorable tolerability profile, and no evidence of dependence.ย ย
In a direct Phase 3 head-to-head comparator study, the drugย also showed superior pain reduction and better gastrointestinal tolerability than opioids.ย ย
In a statement, Dr. Clemens Fischer, CEO of FUTRUE Group and founder ofย Vertanical, said the FDA designation โis a major recognition of its potential to address the significant unmet need in chronic pain.โย
โPatients have waited far too long for meaningful progress. We believe VER-01 has the potential to change how chronic pain is treated and offer physicians a much-needed non-opioid solution.โ โย Fischer in a press releaseย
The Phase 3 results wereย publishedย last September in the journal Nature Medicine. The trialย demonstratedย that the drug โprovides meaningful pain reduction compared to the placebo, accompanied by distinct improvements in physical function and sleep qualityโ and that prolonged treatment โwas associated with further reductions in pain intensity, as well as continued improvements in physical function, sleep quality and health-related quality of life.โย
The company expects marketing
