Grunenthal, in partnership with its U.S. subsidiary Averitas Pharma, has announced the completion of enrollment for the Phase III clinical trial AV001, designed to evaluate the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system in patients suffering from post-surgical neuropathic pain (PSNP). This milestone marks a significant step toward potentially expanding the therapeutic applications of Qutenza, a non-opioid treatment already approved for other neuropathic pain conditions. If the trial yields positive results, Averitas Pharma intends to submit a supplemental new drug application (sNDA) to the FDA in 2026, offering a new treatment option for a patient population with substantial unmet needs.
The AV001 Trial: Design and Objectives
The AV001 trial is a randomized, double-blind, 42-week study involving 410 patients diagnosed with moderate to severe PSNP for at least six months following a surgical procedure. The primary endpoint of the trial is to determine the reduction in average pain intensity after 12 weeks compared to baseline. Secondary endpoints include assessing pain reduction at 42 weeks, evaluating the progressive response to repeated treatments, observing the reduction of the treatment area over multiple applications, and measuring quality of life outcomes such as sleep interference, physical activity, anxiety, and depression.
Post-Surgical Neuropathic Pain: An Unmet Need
Post-surgical neuropathic pain (PSNP) is a chronic condition that emerges after a surgical intervention and persists for a minimum of three months post-surgery. Characterized by symptoms such as burning, stabbing, or shooting pain, numbness, and altered sensitivity to temperature or touch, PSNP affects approximately 10% of all surgical patients, translating to over 3 million individuals in the U.S. each year. Current treatments often involve systemic medications, which can have undesirable side effects, highlighting the need for effective, non-opioid alternatives.
Qutenza: A Topical Solution
Qutenza (capsaicin) 8% topical system is a non-systemic, non-opioid treatment currently approved in the U.S. for neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) of the feet in adults. By potentially adding PSNP to its list of indications, Qutenza could provide a targeted, localized approach to pain management, minimizing systemic exposure and associated side effects.
Expert Perspectives
According to Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma, patients with PSNP often face debilitating complications that are not adequately addressed. She believes Qutenza represents a clinically meaningful treatment option that could fulfill the unmet needs of many PSNP patients who may not find sufficient relief from existing systemic medications. Marv Kelly, President of Averitas Pharma, emphasized that expanding Qutenza's label to include PSNP would further extend access to a much-needed non-opioid therapy for a large, underserved patient population.
Looking Ahead
Topline results from the AV001 trial are anticipated in Q4 2025. If the data are positive, Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the U.S. FDA in 2026, potentially bringing a new, non-opioid treatment option to the millions of Americans suffering from post-surgical neuropathic pain.
