Averitas Pharma, a subsidiary of Grünenthal, has concluded patient enrollment for its Phase III AV001 clinical trial, which is investigating QUTENZA (capsaicin) 8% topical system for the treatment of post-surgical neuropathic pain (PSNP). The double-blind, randomized trial includes 410 patients experiencing moderate to severe PSNP for at least six months.
The trial's primary objective is to demonstrate a significant decrease in average pain intensity at the 12-week mark compared to baseline measurements. Secondary endpoints include assessing pain reduction after 42 weeks, response to repeated treatments, potential reduction in therapy area size after multiple applications, and improvements in quality of life metrics such as physical activity, sleep, anxiety, and depression.
Addressing Unmet Needs in Post-Surgical Pain Management
"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," said Marv Kelly, president of Averitas Pharma. The successful completion of this trial could lead to an expanded indication for QUTENZA in the US market, providing a much-needed non-opioid therapy option for a large, underserved patient population.
Trial Design and Endpoints
The AV001 trial is designed as a 42-week, double-blind, randomized controlled study. The primary endpoint focuses on the change in average pain intensity from baseline to week 12. Secondary endpoints include:
- Change in average pain intensity at week 42
- Progressive response to repeated QUTENZA treatments
- Potential reduction of the therapy area following several applications
- Quality of life improvements (physical activity, sleep, anxiety, depression)
QUTENZA's Existing Indications and Future Prospects
QUTENZA is currently approved in the US for treating neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy (DPN) of the feet in adults. Grünenthal re-launched QUTENZA after acquiring the US rights in 2018. If the AV001 trial yields positive results, Averitas Pharma intends to submit a supplemental new drug application (sNDA) to the FDA in 2026, further expanding QUTENZA's label to include PSNP.
