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

The US Food and Drug Administration (FDA) last month granted Breakthrough Therapy designation to VER-01, a full-spectrum cannabis-derived drug for chronic low back pain made by the 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 addiction.

In a Phase 3 head-to-head comparison 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 that FDA designation “is a great recognition of its potential to address the significant unmet need in chronic pain.”

“Patients have waited too long for meaningful progress. We believe VER-01 has the potential to change the way chronic pain is treated and provide physicians with a much-needed non-opioid solution.” — Fischer in a press release

Phase 3 results were published last September in the journal Nature Medicine. The trial showed that the drug “provides meaningful pain reduction compared to placebo, accompanied by significant improvements in physical function and sleep quality” and that extended treatment “was associated with further reductions in pain intensity as well as sustained 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 US to support a future FDA submission.

The FDA designation, authorized on May 18, came just weeks after the federal government displaced medical cannabis from Schedule I to Schedule III under the Controlled Substances Act.