Grünenthal and its U.S. subsidiary, Averitas Pharma, have announced the completion of patient enrollment in the Phase III clinical trial AV001, designed to evaluate the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system for the treatment of post-surgical neuropathic pain (PSNP). This condition, affecting approximately 10% of all surgical procedures, translates to over 3 million individuals annually in the U.S. who experience debilitating pain following surgery.
Addressing Unmet Needs in Post-Surgical Neuropathic Pain
PSNP is defined as chronic pain persisting at least three months after a surgical procedure, characterized by neuropathic symptoms such as burning, stabbing, or shooting pain, numbness, and altered sensitivity. The AV001 trial is a randomized, double-blind, 42-week study involving 410 patients with moderate to severe PSNP for at least six months. The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline. Secondary endpoints include pain reduction after 42 weeks, progressive response over time, reduction of the treatment area with repeated applications, and improvements in quality of life factors like sleep, physical activity, anxiety, and depression.
Qutenza's Potential in PSNP Management
Qutenza, a non-systemic, non-opioid topical system, is currently approved in the U.S. for neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) in adults. The AV001 trial could potentially expand Qutenza's U.S. label to include PSNP, offering a much-needed alternative for patients dissatisfied with existing systemic medications.
Clinical Trial Design and Anticipated Outcomes
The AV001 trial is designed to be the first blinded, randomized controlled trial evaluating the long-term treatment effects of a topical neuropathic pain treatment in PSNP. According to Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma, Qutenza may offer a clinically meaningful treatment option for patients with PSNP who may not be satisfied with available oral, systemically acting medicines. Topline results are expected in Q4 2025, and Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the FDA in 2026, contingent upon positive data.
Grünenthal's Commitment to Pain Management
Grünenthal acquired the U.S. rights for Qutenza in 2018 and has since expanded its indications to include neuropathic pain associated with diabetic peripheral neuropathy (DPN) in 2020. The potential inclusion of PSNP in the U.S. label would further solidify Qutenza's role in peripheral neuropathic pain management. Marv Kelly, President Averitas Pharma, stated that adding post-surgical neuropathic pain to the U.S. label, if results are positive, would have the potential to fill an unmet treatment need for additional patients in pain.
