FDA Grants Breakthrough Therapy Status to Cannabis-Derived Pain Treatment

Cannabis News Today — 19 May 2026: FDA Backs Cannabis Drug

The downstream effects of April’s federal rescheduling continued to accelerate on Monday. The FDA granted its first Breakthrough Therapy Designation to a pharmaceutical-grade cannabis extract for chronic pain, while California issued emergency regulations enabling roughly 1,600 state licensees to pursue DEA registration before a June deadline. Louisiana’s House advanced end-of-life access legislation, Pennsylvania’s medical programme crossed $9.…

VERTANICAL’s VER-01 gains FDA breakthrough status for low back pain

VERTANICAL has received breakthrough therapy designation from the US FDA for VER-01, its investigational non-opioid treatment for chronic low back pain.

FDA Grants Breakthrough Therapy Status to Cannabis-Derived Pain Treatment

The Marijuana Herald - Marijuana news and information The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to VER-01, a cannabis-derived investigational treatment being developed as a non-opioid option for chronic low back pain. VERTANICAL announced today that the designation was granted after two randomized, controlled Phase 3 trials found that VER-01 produced significant pain reductions, was generally well tolerat…

FDA Grants Breakthrough Therapy Designation to Cannabinoid-Based Treatment

GRÄFELFING, Germany — The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to VER-01, Vertanical’s non-opioid, cannabinoid-extract-based investigational treatment for chronic low back pain. The designation follows two randomized, controlled Phase 3 trials demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence. In a direct Phase 3 head-to-head comparator study, VER-01…