FDA Grants Breakthrough Designation to Vertanical Cannabis-Based Pain Drug

BERLIN – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to VER-01, a Cannabis-derived, non-opioid investigational drug developed by Germany’s VERTANICAL for the treatment of chronic low back pain.

VER-01 is a standardized, pharmaceutical-grade full-spectrum extract from a specific Cannabis sativa strain (DKJ127). It contains primarily THC along with cannabigerol (CBG) and terpenes of β-caryophyllene and α-bisabolol, delivered orally as drops rather than through inhalation. The designation was granted following positive results from European Phase 3 trials, including a placebo-controlled study published in Nature Medicine and a head-to-head comparison against opioids.

VER-01 showed a statistically significant reduction in pain intensity compared with placebo after 12 weeks, with effects that appeared to build and hold over longer periods in extension phases. Researchers noted particular benefits for those with a neuropathic pain component. The treatment was generally well tolerated, with mostly mild to moderate side effects that were transient. Importantly, the studies reported no evidence of dependence or withdrawal symptoms.

VERTANICAL has launched an additional pivotal Phase 3 trial in the United States to support a future FDA submission. The company expects initial data in 2027 and, if results are positive, plans to file a New Drug Application in 2028. European marketing authorization is expected in the first countries within weeks. If approved, VER-01 would be the first full-spectrum Cannabis extract specifically authorized for chronic low back pain, and potentially the first new pharmacological class in chronic pain management in decades.

The FDA’s Breakthrough Therapy Designation is not approval. It is, at its core, a federal agreement to work faster with a company whose drug shows genuine promise. VERTANICAL has earned that by doing what many Cannabis-derived drug developers have not: running rigorous, peer-reviewed, multi-country Phase 3 trials and publishing the results in top-tier journals.

The U.S. data, due in 2027, will be the real test of whether those European results translate across a broader patient population. If they do, VER-01 could put a Cannabis-derived medicine at the center of mainstream pain care – not a supplement or an alternative, but as a first-line prescription option. That would be a different kind of breakthrough altogether.