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, the drug also showed superior pain reduction and better gastrointestinal tolerability than opioids.
In a statement, Dr. Clemens Fischer, CEO of FUTRUE Group and founder of Vertanical, said the FDA designation “is a major recognition of its potential to address the significant unmet need in chronic pain.”
“Patients 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.” — Fischer in a press release
The Phase 3 results were published last September in the journal Nature Medicine. The trial demonstrated that the drug “provides meaningful pain reduction compared to the placebo, accompanied by distinct improvements in physical function and sleep quality” and that prolonged treatment “was associated with further reductions in pain intensity, as well as continued improvements in physical function, sleep quality and health-related quality of life.”
The company expects marketing authorization in the first European countries in the coming weeks, but has also initiated an additional Phase 3 trial in the U.S. to support a future FDA submission.
The FDA designation, authorized on May 18, came just weeks after the federal government moved medical cannabis from Schedule I to Schedule III under the Controlled Substances Act.
