Grünenthal and Averitas Pharma Complete Recruitment for Phase III Trial of QUTENZA® in Post-Surgical Neuropathic Pain

Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc., has finished patient enrollment for the Phase III AV001 clinical trial. This trial aims to assess the efficacy, safety, and tolerability of QUTENZA® (capsaicin) 8% topical system in treating post-surgical neuropathic pain (PSNP), with the potential to expand its U.S. approval if successful. The randomised, double-blind study will span 42 weeks and involve 410 patients who have experienced moderate to severe PSNP for a minimum of six months. The primary objective is to evaluate pain intensity reduction after 12 weeks compared to baseline.

The trial will also explore secondary endpoints, including pain intensity changes after 42 weeks, the cumulative effect of repeated treatments, the impact of reducing the treatment area, and quality of life factors such as sleep disruption, physical activity, anxiety, and depression. Upon completion, AV001 will be the first randomised controlled trial to investigate the long-term effects of a topical treatment for post-surgical neuropathic pain.

Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma, stated, “Patients who undergo surgery and end up developing post-surgical neuropathic pain, may experience debilitating complications that often are not treated appropriately. 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 Post-surgical neuropathic pain 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.”

Marv Kelly, President Averitas Pharma, said in a statement, “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. 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 secured the U.S. rights to Qutenza® in 2018, initially approved for the treatment of neuropathic pain linked to postherpetic neuralgia. Since then, the company has relaunched the product, significantly improving patient access to Qutenza®. In 2020, the U.S. FDA expanded its approval to include neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. With the AV001 trial, Grünenthal and Averitas aim to add another significant indication for peripheral neuropathic pain to the U.S. label. Topline results are expected by the fourth quarter of 2025, and if the data is positive, Averitas Pharma plans to file a supplemental new drug application (sNDA) in 2026.