Grünenthal and its U.S. subsidiary, Averitas Pharma, have announced the completion of recruitment for the Phase III clinical trial AV001, designed to evaluate Qutenza (capsaicin 8% topical system) for the treatment of post-surgical neuropathic pain (PSNP). This randomized, double-blind trial includes 410 patients and aims to provide a non-opioid treatment option for a condition affecting over 3 million people annually in the U.S. following surgical procedures.
Addressing Post-Surgical Neuropathic Pain
Post-surgical neuropathic pain (PSNP) is a chronic condition that develops after surgery and persists beyond the typical healing period, generally defined as lasting at least three months. Characterized by symptoms such as burning, stabbing, or shooting pain, numbness, and altered sensitivity, PSNP occurs in approximately 10% of all surgical cases. Current treatments often involve systemic medications, and Qutenza offers a potential topical alternative.
Trial Design and Endpoints
The AV001 trial is a 42-week, randomized, double-blind study. The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline. Secondary endpoints include assessing pain reduction after 42 weeks, evaluating progressive response over time with repeated treatment, reduction of the treatment area over several applications, and improvements in quality of life outcomes such as sleep, physical activity, anxiety, and depression.
Qutenza's Mechanism and Current Indications
Qutenza is a topical, 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. The active ingredient, capsaicin, works by desensitizing pain receptors in the skin.
Future Implications
"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,” said Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma. Topline results from the AV001 trial are expected in Q4 2025, and if the data are positive, Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the FDA in 2026, potentially expanding the availability of this non-opioid option for patients with PSNP.
