Aachen, Germany & Morristown, N.J. – Grünenthal, a global leader in pain management and related diseases, announced today that its U.S. subsidiary, Averitas Pharma, Inc., has completed recruitment for the Phase III clinical trial AV001. The trial aims to evaluate the efficacy, safety, and tolerability of QUTENZA® (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP). If successful, the trial could support an extension of the U.S. label for QUTENZA®.
Post-surgical neuropathic pain (PSNP) is a chronic pain condition that develops after a surgical procedure and persists for at least three months after the surgery. It is identified by symptoms of neuropathic nerve pain such as burning, stabbing, or shooting pain, numbness, and changes to physical sensation or sensitivity to temperature or touch. According to recent studies, approximately 10% of all surgical procedures result in PSNP, affecting more than 3 million people in the U.S. per year.
QUTENZA® is a topical system, non-systemic, non-opioid pain treatment that is currently approved in the U.S. for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a U.S. label extension in 2026, subject to positive data.
“Patients who undergo surgery and develop post-surgical neuropathic pain may experience debilitating complications that are often not treated appropriately,” says Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma. “We believe QUTENZA® may be a clinically meaningful treatment option that could address the unmet needs of many patients in the United States who suffer from PSNP and may not be satisfied with available oral, systemically acting medicines. We look forward to completing the Clinical Trial with the goal to file a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in 2026, assuming positive data.”
The randomized, double-blind 42-week trial includes 410 patients who have been suffering from moderate to severe PSNP for at least six months. The primary endpoint of the trial is a reduction in the average pain intensity after 12 weeks compared to baseline. In addition, the trial assesses other outcomes including reduction in the average pain intensity after 42 weeks, progressive response over time with repeated treatment, reduction of the treatment area over several applications, and quality of life outcomes such as sleep interference, physical activity, anxiety, and depression. When completed, AV001 will be the first blinded randomized controlled trial in PSNP that evaluates the long-term treatment effects of a topical neuropathic pain treatment.
“The completion of enrollment is an exciting milestone. With our current indications, adults with painful diabetic peripheral neuropathy of the feet and postherpetic neuralgia, we have advanced the trajectory of QUTENZA® in the U.S. by expanding access to a much-needed non-opioid therapy option for a large, underserved patient population,” adds Marv Kelly, President Averitas Pharma. “By adding post-surgical neuropathic pain to the U.S. label if results are positive, we would have the potential to fill an unmet treatment need for additional patients in pain.”
Grünenthal acquired the U.S. rights for QUTENZA® in 2018, and since then, the U.S. label has been expanded to include the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. With AV001, Grünenthal and Averitas hope to include another major indication in the field of peripheral neuropathic pain in the U.S. label. Topline results are anticipated in Q4 2025, and assuming positive data, Averitas Pharma aims to submit a supplemental new drug application (sNDA) in 2026.
About QUTENZA
QUTENZA® (capsaicin) 8% topical system is approved in the U.S. for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. In Europe, QUTENZA® is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain.
About post-surgical neuropathic pain
Post-surgical neuropathic pain (PSNP) is defined as chronic pain that develops after a surgical procedure and persists beyond the healing process, i.e., at least three
