FDA grants breakthrough therapy designation to Vertanical's VER-01, a first in class non-opioid investigational treatment for chronic low back pain

Vertanical

18 May 2026 - Vertanical today announced that the US FDA has granted breakthrough therapy designation to VER-01, the company's first in class non-opioid investigational treatment for chronic low back pain.

The FDA breakthrough therapy designation has been granted after two randomised, controlled Phase 3 trials demonstrated significant pain reduction, a favourable tolerability profile, and no evidence of dependence.

Read Vertanical press release

Michael Wonder

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Michael Wonder