Cannabis Formula Granted ‘Breakthrough’ Designation By FDA For Lower Back Pain Treatment

Pharmaceutical company VERTANICAL announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to VER-01, the company's investigational non-opioid, cannabis-based treatment for chronic low back pain. VER-01 is a standardized full-spectrum extract derived from the cannabis sativa strain DKJ127 L.

The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of investigational treatments where early clinical evidence suggests meaningful improvement over existing therapies. The designation was supported by two randomized, controlled Phase 3 clinical trials demonstrating significant pain reduction, favorable tolerability, and no evidence of dependence . . .