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 tolerated and showed no evidence of dependence. In a direct Phase 3 comparison study, the company said VER-01 also produced greater pain reduction and better gastrointestinal tolerability than opioids.

Breakthrough Therapy Designation is intended to speed the development and review of investigational treatments when preliminary clinical evidence indicates they may offer a substantial improvement over available therapies.

VER-01 is a standardized full-spectrum extract derived from the Cannabis sativa strain DKJ127 L., a proprietary plant variety selected for chronic pain treatment. The product includes a defined mixture of cannabinoids, terpenes and other bioactive compounds, with pharmaceutical-grade standardization meant to ensure consistency across production.

“The FDA’s Breakthrough Therapy Designation for VER-01 is a major recognition of its potential to address the significant unmet need in chronic pain,” said Dr. Clemens Fischer, CEO of FUTRUE Group and founder of VERTANICAL. “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.”

The designation is supported by VERTANICAL’s European Phase 3 clinical program. In a placebo-controlled Phase 3 study published in Nature Medicine last September, VER-01 met its primary endpoint by significantly reducing pain compared to placebo, with effects maintained during long-term treatment. Patients also reported improvements in sleep disturbances and physical function, both common issues tied to chronic pain.

The company said it expects marketing authorization in the first European countries in the coming weeks. VERTANICAL has also launched an additional pivotal Phase 3 trial in the United States to support a future FDA submission.

That U.S. trial is designed to confirm VER-01’s safety and effectiveness in American patients with chronic low back pain. The company anticipates initial data in 2027 and, if results are positive, plans to submit a New Drug Application in 2028.

VERTANICAL said VER-01 is distinct from other cannabis products because of its specific plant genetics, formulation and manufacturing standards, meaning findings from its trials should not be applied to other cannabis extracts or products.