Williamsville, NY: Investigators in western New York have been authorized to begin a clinical trial assessing the safety and efficacy of a proprietary cannabis extract (VER-01) containing 2.5 milligrams of THC and standardized percentages of CBD and CBG (cannabigerol).
VER-01, which is manufactured in Germany by Vertanical, was granted ‘Breakthrough Therapy Designation’ by the US Food and Drug Administration this summer. The FDA made its decision following the results of a Phase 3 clinical trial in Europe, which concluded that patients who consumed the cannabis extract experienced greater mean pain reductions than those taking opioids.
Investigators affiliated with Upstate Clinical Research Associates in Williamsville (near Buffalo) will oversee the placebo-controlled trial, according to a press release issued by the New York State Office of Cannabis Management. The trial will involve patients with lower back pain who have been unresponsive to opioid-based treatments. The trial will eventually involve patients enrolled in pain centers in multiple states.
Israeli data published last month in the European Spine Journal concluded that cannabis products provide long-term pain relief and greatly reduce the need for pharmaceutical interventions in patients with refractory lower back pain. Specifically, patients’ daily opioid intake fell nearly 90 percent during the study. Participants also reported significant decreases in their use of SSRIs, gabapentin, benzodiazepines, and tramadol.
VER-01 has previously received market approval in Germany under the name Exilby.
The press release is available from New York State’s Office of Cannabis Management. Additional information on cannabis and chronic pain is available from NORML’s publication, Clinical Applications for Cannabis and Cannabinoids.