The New York Cannabis Control Board (CCB) has approved a first-of-its-kind study focused on the efficacy of an oral THC solution for chronic pain. The new research license is for the use of VER-01 for people experiencing chronically painful lumbosacral radiculopathy, commonly known as sciatica.
In a statement, John Kagia, executive director of the New York Office of Cannabis Management, called the approval “an important moment for cannabis research in New York and for the future of evidence-based cannabis medicine.”
“For decades prohibition and criminalization limited the ability of researchers to fully understand cannabis and its potential therapeutic applications. Clinical trials like these give us the opportunity to develop safe and effective solutions for people living with conditions that can be difficult to treat. We are grateful that the VER-01 team chose to do this important study in New York as we work to make the state a leading global center for cannabis science and research.” — Kagia in a press release
Researchers will compare VER-01 with a placebo to determine whether it provides greater pain relief. The trial will also examine whether any benefits are maintained over time and assess any long-term safety concerns for participants.
In a statement, Dr. James E. Wild of Upstate Clinical Research Associates, which will lead the study, said the researchers are “committed to conducting the study with the highest standards of patient safety, scientific integrity, and regulatory compliance.”
“We are proud to contribute to research that may help advance our understanding of new treatment options for patients living with chronic low back pain,” he said.
Dr. Nakesha Abel, director of Scientific Programs & Research Health & Scientific Affairs at OCM, added that “Clinical research allows us to move beyond anecdote and evaluate cannabis-based medicines with the same rigor applied to any other therapy.”
“Well-designed trials help clarify not only whether a treatment is effective, but at what dose, for which patients, and with what risks,” Abel said in a statement. “That evidence is what guides sound clinical and regulatory decisions.”
The treatment being studied is intended for patients whose pain has not been adequately managed with non-opioid pain medications.
The research will be conducted by Upstate Clinical Research Associates on behalf of the study sponsor, Vertanical GmbH, as well as at other participating research sites across the country.
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