Grünenthal’s U.S. subsidiary, Averitas Pharma, Inc., has completed recruitment for their Phase III clinical trial AV001. The trial aims to investigate the efficacy, safety and tolerability of QUTENZA® (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) and, if successful, could support an extension of the U.S. label.
PSNP is defined as chronic pain that develops after a surgical procedure and persists beyond the healing process, affecting approximately 10 percent of all surgical procedures. This equates to more than 3 million people with surgical procedures per year in the U.S.
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. The drug has shown to be effective in reducing pain intensity in these conditions and is administered by healthcare professionals.
Dr. Lizandra Marcondes, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma, stated, “Patients who undergo surgery and end up developing post-surgical neuropathic pain, may experience debilitating complications that often are not treated appropriately. We believe QUTENZA® may be a clinically meaningful treatment option that could address the unmet needs of many patients in the United States who suffer from Post-surgical neuropathic pain and may not be satisfied with available oral, systemically acting medicines.”
The randomized, double-blind 42-week trial includes 410 patients who have been suffering from moderate to severe PSNP for at least six months. The primary endpoint of the trial is a reduction in the average pain intensity after 12 weeks compared to baseline. Other outcomes being assessed include reduction in the average pain intensity after 42 weeks, progressive response over time with repeated treatment, reduction of the treatment area over several applications, and quality of life outcomes such as sleep interference, physical activity, anxiety, and depression. 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.
Marv Kelly, President Averitas Pharma, added, “By adding post-surgical neuropathic pain to the U.S. label if results are positive, we would have the potential to fill an unmet treatment need for additional patients in pain.”
QUTENZA® was acquired by Grünenthal in 2018, and the U.S. label initially comprised the treatment of neuropathic pain associated with postherpetic neuralgia. Since then, access to the drug has been significantly increased, and in 2020, it was also approved in the U.S. for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. With AV001, Grünenthal and Averitas hope to include another major indication in the field of peripheral neuropathic pain in the U.S. label.
Christopher Jansen, Global Corporate Affairs, stated, “Grünenthal is a global leader in pain management and related diseases. Our purpose is to change lives for the better – and innovation is our passion.”
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