Grünenthal and Averitas Pharma complete Phase III trial recruitment for QUTENZA® in post-surgical neuropathic pain

Grünenthal has announced that its U.S. subsidiary, Averitas Pharma, has finished enrolling participants for the Phase III clinical trial AV001. This trial is designed to evaluate the effectiveness, safety, and tolerability of QUTENZA® (capsaicin) 8% topical system for post-surgical neuropathic pain (PSNP). If the trial results are positive, it could lead to an extension of the U.S. label for QUTENZA®.

QUTENZA® is a non-opioid, non-systemic pain treatment currently approved in the U.S. for neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy in adults. The completion of the trial is expected by the fourth quarter of 2025, and subject to favorable results, Averitas Pharma plans to submit a supplemental new drug application (sNDA) in 2026.

Lizandra Marcondes, Senior VP Medical Affairs & Drug Safety at Averitas Pharma, emphasized the significance of QUTENZA® as a potential treatment for patients suffering from post-surgical neuropathic pain, a condition that can result in debilitating pain and is often inadequately treated. Marcondes stated that the company aims to address an unmet need for many patients in the U.S. who do not find relief with current oral, systemically acting medications.

The AV001 trial is a 42-week, randomized, double-blind study involving 410 patients experiencing moderate to severe PSNP for at least six months. The primary goal of the trial is to achieve a reduction in the average pain intensity after 12 weeks compared to baseline. Other outcomes being measured include the reduction in pain intensity after 42 weeks, the response over time with repeated treatments, the reduction of the treatment area, and improvements in quality of life aspects such as sleep interference, physical activity, anxiety, and depression. This trial is noteworthy as it will be the first blinded randomized controlled trial to evaluate the long-term effects of a topical neuropathic pain treatment for PSNP.

Marv Kelly, President of Averitas Pharma, highlighted the milestone of completing enrollment and the potential to expand QUTENZA®'s indications. With its current use for diabetic peripheral neuropathy of the feet and postherpetic neuralgia, QUTENZA® has already provided a much-needed non-opioid therapy option for a significant patient population. Adding PSNP to the U.S. label could further address the treatment needs of additional patients suffering from pain.

Grünenthal acquired the U.S. rights for QUTENZA® in 2018, initially approved for treating neuropathic pain associated with postherpetic neuralgia. Since then, the company has relaunched the product and increased patient access. In 2020, the U.S. FDA approved QUTENZA® for treating neuropathic pain related to diabetic peripheral neuropathy in adults. With the ongoing AV001 trial, Grünenthal and Averitas aim to include another major indication in the U.S. label for peripheral neuropathic pain.

Post-surgical neuropathic pain is defined as chronic pain that develops after a surgical procedure and lasts beyond the healing process, typically at least three months post-surgery. This condition affects more than 3 million people annually in the U.S. and is characterized by symptoms such as burning, stabbing, or shooting pain, numbness, and changes in physical sensation or sensitivity to temperature or touch.

Averitas Pharma, established in 2018 as a Grünenthal Group subsidiary, focuses on providing innovative, effective, non-opioid pain management solutions in the U.S. Grünenthal, a global leader in pain management, is based in Aachen, Germany, with affiliates in 27 countries and products available in about 100 countries. In 2023, the company employed approximately 4,400 people and generated revenues of €1.8 billion.