Grünenthal and its U.S. subsidiary, Averitas Pharma, have announced the completion of patient enrollment for the Phase III clinical trial AV001, designed to assess the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system in treating post-surgical neuropathic pain (PSNP). This condition affects approximately 10% of all surgical procedures, impacting over 3 million individuals annually in the U.S.
AV001 Trial Details
The AV001 trial is a randomized, double-blind, 42-week study that includes 410 patients experiencing 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 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 factors such as sleep, physical activity, anxiety, and depression.
Addressing Unmet Needs in PSNP
According to Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US at Averitas Pharma, many patients who develop post-surgical neuropathic pain 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.
Qutenza's Current Indications and Potential Expansion
Qutenza is currently approved in the U.S. for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) of the feet in adults. Marv Kelly, President of Averitas Pharma, noted that expanding the label to include PSNP could "fill an unmet treatment need for additional patients in pain."
Regulatory Timeline
Topline results from the AV001 trial are expected in Q4 2025. Assuming positive data, Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in 2026.
About Post-Surgical Neuropathic Pain (PSNP)
PSNP is defined as chronic pain that persists beyond the normal healing process (at least three months post-surgery). It is characterized by neuropathic symptoms such as burning, stabbing, or shooting pain, numbness, and altered sensitivity to temperature or touch. PSNP can significantly impair a patient's quality of life and functional abilities.
