Phase III Trial of Qutenza® for Post-Surgical Neuropathic Pain Completes Enrollment
• Grünenthal and Averitas Pharma have completed recruitment for a Phase III trial (AV001) evaluating Qutenza® (capsaicin) 8% topical system for post-surgical neuropathic pain (PSNP).
• The randomized, double-blind trial includes 410 patients and assesses the efficacy, safety, and tolerability of Qutenza® over 42 weeks, with topline results expected in Q4 2025.
• The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline, with secondary endpoints including long-term pain reduction and quality of life improvements.
• Averitas Pharma aims to submit a supplemental new drug application (sNDA) to the FDA in 2026, assuming positive data, to expand Qutenza's label to include PSNP.
GrĂĽnenthal Completes Enrollment for Phase III Trial of Qutenza in Post-Surgical Neuropathic Pain
• Grünenthal and Averitas Pharma have completed recruitment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP).
• The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin 8% topical system) in patients suffering from moderate to severe PSNP.
• Topline results from the AV001 trial are expected in Q4 2025, with a potential sNDA submission to the FDA for a U.S. label extension in 2026.
• PSNP affects approximately 10% of surgical patients, representing a significant unmet need for non-opioid pain management options.
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