Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain7.11.2024 11:26:47 CET | Grünenthal Group | Press release
The Phase III trial AV001 aims to evaluate QUTENZA® in post-surgical neuropathic pain (PSNP), a debilitating complication of surgery occurring after approximately 10 percent of all surgical procedures[1], thus affecting more than 3 million people with surgical procedures per year in the U.S.[2] QUTENZA® is a topical system, non-systemic, non-opioid pain treatment that is currently approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Topline results are expected in Q4 2025 and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data.