VERTANICAL Secures FDA Breakthrough Therapy Status for VER-01 for Chronic Back Pain
VERTANICAL has achieved an important regulatory milestone after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to VER-01, an investigational non-opioid therapy being developed for chronic low back pain.
The designation follows positive findings from late-stage clinical studies, where VER-01 demonstrated meaningful reductions in pain levels and a favourable safety profile.
Clinical data also indicated that the treatment was associated with better gastrointestinal tolerability than opioid-based therapies and showed no signs of dependence-related concerns.
Chronic pain continues to affect millions of people worldwide, creating a significant healthcare burden and highlighting the need for new treatment options beyond traditional opioid medicines.
VER-01 is being developed to offer a different therapeutic approach for patients requiring long-term pain management.
Results from the company's European Phase 3 programme showed improvements not only in pain control but also in patient-reported outcomes such as sleep and physical functioning.
Building on these findings, VERTANICAL has launched a pivotal Phase 3 study in the United States to further evaluate the treatment in patients with chronic low back pain.
The company expects preliminary data from the U.S. trial in 2027 and aims to pursue regulatory approval through a New Drug Application planned for 2028, subject to successful study outcomes.
