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news.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.
VERTANICAL is undertaking a pivotal Phase III US trial for future FDA submission. Credit: Gorodenkoff / Shutterstock.com.
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The designation follows two randomised, controlled Phase III trials that showed significant pain reduction, good tolerability, and no evidence of dependence.
A Phase III comparator study found VER-01 delivered greater pain relief and improved gastrointestinal tolerability versus opioids, supporting its potential as a differentiated chronic pain alternative.
The FDA designation is designed to accelerate the development and review process for treatments with early signs of substantial improvement over current therapies.
According to VERTANICAL, chronic pain remains among the largest unmet healthcare needs, affecting more than one billion worldwide, including over 60 million people in the US.
With a new mechanism of action, VER-01 offers an investigational approach distinct from traditional treatment paradigms.
VERTANICAL anticipates marketing authorisation in the first European countries shortly and is conducting an additional pivotal Phase III trial in the US to support future FDA submission.
VERTANICAL founder and FUTRUE Group CEO Dr Clemens Fischer said: “The FDA’s breakthrough therapy designation for VER-01 is a major recognition of its potential to address the significant unmet need in chronic pain.
“Patients have waited far too long for meaningful progress. We believe VER-01 has the potential to change how chronic pain is treated and offer physicians a much-needed non-opioid solution.”
Results from VERTANICAL’s European Phase III programme confirm significant pain reduction, achievement of the primary endpoint, and sustained effects during long-term use.
VER-01 also improved sleep and physical function, showed tolerable side effects, and demonstrated no evidence of dependence. The company targets first US data in 2027 and a new drug application by 2028.
