Grünenthal and its U.S. subsidiary, Averitas Pharma, have announced the completion of recruitment for the Phase III clinical trial AV001, designed to evaluate the efficacy, safety, and tolerability of Qutenza® (capsaicin) 8% topical system in treating post-surgical neuropathic pain (PSNP). This condition, affecting approximately 10% of all surgical procedures, translates to over 3 million individuals annually in the U.S. who experience debilitating complications following surgery. The successful completion of this trial could lead to an extension of Qutenza's U.S. label, offering a new non-opioid treatment option.
Addressing Unmet Needs in Post-Surgical Neuropathic Pain
According to Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US at Averitas Pharma, many patients who develop PSNP do not receive adequate treatment. "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," she stated. The goal is to file a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in 2026, contingent upon positive data from the AV001 trial.
Trial Design and Endpoints
AV001 is a randomized, double-blind, 42-week trial involving 410 patients who have experienced moderate to severe PSNP for at least six months. The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline. Secondary endpoints include assessing pain reduction after 42 weeks, progressive response over time with repeated treatment, reduction of the treatment area over several applications, and improvements in quality of life outcomes such as sleep interference, physical activity, anxiety, and depression.
Qutenza's Current Indications and Potential Expansion
Qutenza is currently approved in the U.S. for treating neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) of the feet in adults. Marv Kelly, President of Averitas Pharma, noted, "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."
About Post-Surgical Neuropathic Pain (PSNP)
PSNP is defined as chronic pain that persists beyond the normal healing process, typically lasting at least three months after surgery. Patients often experience symptoms such as burning, stabbing, or shooting pain, numbness, and altered sensitivity to temperature or touch. This condition can significantly impact a patient's quality of life and ability to perform daily activities.
