Grünenthal and its U.S. subsidiary, Averitas Pharma, have announced the completion of recruitment for the Phase III clinical trial AV001, designed to evaluate the efficacy, safety, and tolerability of Qutenza® (capsaicin) 8% topical system in patients with post-surgical neuropathic pain (PSNP). This trial, if successful, could lead to an extension of Qutenza's U.S. label.
Addressing Unmet Needs in Post-Surgical Neuropathic Pain
Post-surgical neuropathic pain can be a debilitating complication following surgery, often inadequately treated. The AV001 trial aims to assess whether Qutenza® can provide a clinically meaningful treatment option for these patients, who may not find sufficient relief from existing systemic medications.
Trial Design and Endpoints
The AV001 trial is a randomized, double-blind, 42-week study involving 410 patients suffering from 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 assessing pain reduction after 42 weeks, evaluating progressive response over time with repeated treatment, reduction of the treatment area over several applications, and measuring quality of life outcomes such as sleep interference, physical activity, anxiety, and depression.
Potential Impact and Future Steps
Completion of enrollment marks a significant milestone for the AV001 trial. Grünenthal and Averitas Pharma anticipate topline results in Q4 2025. If the data are positive, Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in 2026 to include PSNP as an indication for Qutenza®.
Qutenza® is currently approved in the U.S. for the treatment of neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy (DPN) of the feet in adults. The potential addition of PSNP to the label could significantly expand the availability of this non-opioid therapy option to a larger patient population.
