VERTANICAL’s VER-01 gains FDA breakthrough status for low back pain

VERTANICAL has received breakthrough therapy designation from the US FDA for VER-01, its investigational non-opioid treatment for chronic low back pain. VER-01 offers an investigational approach distinct from traditional treatment paradigms. VERTANICAL is undertaking a pivotal Phase III US trial for future FDA submission. Credit: Gorodenkoff / Shutterstock.com. VERTANICAL has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for VER-01, its investigational non-opioid treatment for chronic low back pain. The designation follows two randomised, controlled Phase III trials that showed significant pain reduction, good tolerability, and no evidence of dependence. LOA and PTSR Model (Acetaminophen…

Source: Pharmaceutical Technology