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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.

Janneke van der Kamp has today assumed her role as the new Chief Commercial Officer (CCO) of Grünenthal. She joins Grünenthal’s executive board and is responsible for the entire Global Commercial Organisation.

The study AV001 aims to include the treatment of post-surgical neuropathic pain (PSNP) in the U.S. label. QUTENZA® is currently approved for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Post-surgical neuropathic pain is a debilitating complication of surgery that affects approximately 13% of all patients who undergo surgery, representing 3.3 million patients per year in the US.[1] Aachen, Germany, & Morristown, N.J., 10 August 2021 –Grünenthal announced today that its U.S. subsidiary, Averitas Pharma Inc., enrolled the first patient in the randomised, double-blind trial AV001. The Phase III study investigates the efficacy, safety, and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) to support an extension of the U.S. label. The trial will include over 400 patients who suffer from moderate to seve

Post-surgical neuropathic pain (PSNP) is a debilitating complication of surgery that affects approximately 13 percent of all patients who undergo surgery, which represents 3.3 million patients per year in the US.[1] This Phase III study is Grünenthal’s next step in making QUTENZA available to even more patients in the United States. QUTENZA is the first and only prescription strength capsaicin that is a topical, non-systemic, non-opioid pain treatment; it is currently approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia, and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Aachen, Germany, & Morristown, N.J., 30 March 2021 –Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc. will conduct a Phase III trial to study the efficacy, safety and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) with the goal to expand t