New York Approves Research License for First U.S. Human Trial of Cannabis-Based VER-01 for Chronic Pain
- New York regulators have approved a cannabis research license for Upstate Clinical Research Associates in Williamsville to participate in the first U.S. human clinical trial of VER-01, an oral cannabis-based medicine for chronic pain.
- The nationwide study will evaluate VER-01, a THC-containing oral solution, in patients suffering from chronic painful lumbosacral radiculopathy (sciatica) who have not responded to non-opioid pain medications.
- Researchers will compare VER-01 to a placebo to assess pain relief efficacy, long-term benefits, and safety, aiming to move beyond anecdotal evidence with rigorous clinical standards.
- The trial marks a significant step for cannabis research in New York, positioning the state as a leader in cannabis science and emphasizing the importance of evidence-based cannabis medicine development.
New York regulators have approved a cannabis research license allowing a Williamsville laboratory to participate in the first U.S. human clinical trial of VER-01, an oral cannabis-based medicine being studied as a potential treatment for chronic pain.
The New York Office of Cannabis Management (OCM) announced today that the Cannabis Control Board approved the research license for Upstate Clinical Research Associates, which will participate in a nationwide study evaluating VER-01 in people with chronic painful lumbosacral radiculopathy, commonly known as sciatica.
VER-01 is an oral solution containing THC derived from cannabis. According to OCM, the study represents the first U.S. clinical trial involving human testing of the medicine.
Researchers will compare VER-01 with a placebo to determine whether the treatment provides greater pain relief. The trial will also examine whether any benefits are maintained over time and evaluate the medicine’s longer-term safety.
The treatment is being studied in patients whose pain has not been adequately controlled with non-opioid pain medications.
“This is an important moment for cannabis research in New York and for the future of evidence-based cannabis medicine,” said John Kagia, executive director of OCM. “For decades prohibition and criminalization limited the ability of researchers to fully understand cannabis and its potential therapeutic applications.”
Kagia said clinical trials provide an opportunity to develop safe and effective treatments for conditions that can be difficult to manage, while helping position New York as a center for cannabis science and research.
Dr. James E. Wild of Upstate Clinical Research Associates said the Williamsville team is committed to conducting the study under rigorous standards for patient safety, scientific integrity and regulatory compliance.
“Clinical research allows us to move beyond anecdote and evaluate cannabis-based medicines with the same rigor applied to any other therapy,” said Dr. Nakesha Abel, director of Scientific Programs & Research Health & Scientific Affairs at OCM.
Abel said well-designed clinical trials can help determine not only whether cannabis-based treatments work, but appropriate dosing, which patients may benefit and what risks may be associated with treatment.
The New York portion of the study will be conducted by Upstate Clinical Research Associates in Williamsville on behalf of study sponsor Vertanical GmbH. Other research sites across the United States will also participate in the trial.
Clinical trials are required to generate safety, dosing and effectiveness data before investigational medicines can potentially advance toward regulatory approval.