- The study AV001 aims to include the treatment of post-surgical neuropathic pain (PSNP) in the U.S. label. QUTENZA® is currently approved for use in adults in 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.
- 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.
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….