Regulators at the US Food and Drug Administration have granted ‘Breakthrough Therapy Designation’ to a proprietary cannabis extract (VER-01) containing 2.5 milligrams of THC and standardized percentages of CBD and CBG (cannabigerol).
A press release issued by the product’s manufacturer, VERTANICAL, states that the designation “is intended to expedite the development and review of investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies.”
The FDA’s decision follows the results of a Phase 3 clinical trial concluding that patients who consumed the cannabis extract experienced greater mean pain reductions than did those taking opioids.
“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, 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 company anticipates that European regulators will authorize the product soon and says that it will commence additional Phase 3 trials in the United States prior to seeking FDA approval.
In 2018, the FDA granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) and other compounds, for the explicit treatment of two rare forms of severe epilepsy.
Other cannabis-based drugs approved by the FDA include dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). The latter three prescription drugs all contain synthetic forms of cannabinoids.
VERTANICAL’s press release is available from PR Newswire.
