Averitas Pharma, a subsidiary of Grünenthal, has concluded patient recruitment for the Phase III AV001 clinical trial, which is evaluating QUTENZA (capsaicin) 8% topical system for the treatment of post-surgical neuropathic pain (PSNP). The double-blind, randomized trial, spanning 42 weeks, includes 410 patients experiencing moderate to severe PSNP for at least six months.
The AV001 trial aims to assess the safety, efficacy, and tolerability of QUTENZA in this patient population. The primary endpoint is the change in average pain intensity at the 12-week mark compared to baseline measurements. Secondary endpoints include the decline in average pain intensity after 42 weeks, progressive response to repeated treatments, potential reduction of the therapy area following several applications, and quality of life metrics such as physical activity, sleep interference, and psychological aspects like anxiety and depression.
Potential Impact on PSNP Treatment
If successful, this trial could lead to an expanded indication for QUTENZA in the US market. Currently, QUTENZA is approved for treating neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy (DPN) of the feet in adults. The addition of PSNP to the US label would address an unmet treatment need for a significant patient population.
Marv Kelly, president of Averitas Pharma, stated, "The completion of enrolment is an exciting milestone... By adding post-surgical neuropathic pain to the US label if results are positive, we would have the potential to fill an unmet treatment need for additional patients in pain."
Trial Design and Endpoints
The AV001 trial is designed as a double-blind, randomized controlled study. Patients with moderate to severe PSNP for a minimum of six months were enrolled. The primary outcome measure focuses on pain reduction at 12 weeks. The study also evaluates the long-term effects of topical neuropathic pain treatment, assessing outcomes at 42 weeks and beyond.
Future Steps
Topline outcomes from the trial are expected in the fourth quarter of 2025. Assuming positive data, Averitas Pharma plans to submit a supplemental new drug application (sNDA) to the FDA in 2026, seeking approval for QUTENZA in the treatment of post-surgical neuropathic pain.
