VERTANICAL Introduces Breakthrough VER-01 Therapy for Treating Chronic Low Back Pain
VERTANICAL has introduced VER-01 for the treatment of chronic low back pain, a condition associated with persistent pain and functional impairment.
VER-01 is a first-in-class investigational non-opioid therapy derived from a standardized full-spectrum Cannabis sativa extract. The therapy is designed to provide effective pain relief through a novel mechanism of action while avoiding the dependence, abuse potential and adverse effects associated with opioid treatments.
The Breakthrough Therapy Designation is supported by results from two Phase 3 clinical studies, in which VER-01 demonstrated statistically significant reductions in pain, superior gastrointestinal tolerability compared with opioid therapy and no evidence of dependence or withdrawal symptoms. In a placebo-controlled Phase 3 study, the therapy met its primary endpoint with sustained improvements in pain during long-term treatment. Patients also experienced improvements in sleep disturbances and physical function.
Chronic low back pain is one of the leading causes of disability globally and affects more than one billion people worldwide. Opioids continue to play a central role in pain management but are associated with risks including dependence, abuse potential and significant side effects. As a result, there remains a substantial need for safe and effective non-opioid treatment options for patients with chronic pain.
VER-01 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), which is intended to accelerate the development and review of therapies that may offer substantial improvements over existing treatments. The therapy is currently being evaluated in an additional pivotal Phase 3 clinical trial in the United States to support a future New Drug Application (NDA), with initial study results expected in 2027.
VER-01 is being developed as a first-in-class non-opioid therapy aimed at providing long-term pain relief while reducing the risks associated with conventional opioid treatment for chronic low back pain.
