Grunenthal, a Germany-based pharmaceutical company, announced on Thursday that its US subsidiary, Averitas Pharma Inc, has completed enrollment of patients for the Phase III clinical trial AV001 to assess QUTENZA (capsaicin).

The trial is intended to assesses the efficacy, safety and tolerability of QUTENZA (capsaicin) eight percent topical system in post-surgical neuropathic pain (PSNP), and if successful, it is to support an extension of the US label.

AV001, a randomised, double-blind 42-week trial, includes 410 patients who have been suffering from moderate to severe PSNP for around six months. The study's primary endpoint is a reduction in the average pain intensity after 12 weeks compared to baseline. The trial also evaluates other results, including 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 results like sleep interference, physical activity, anxiety, and depression. The company says that when completed, the trial will be the first blinded randomised controlled study in post-surgical neuropathic pain that assesses the long-term treatment impact of a topical neuropathic pain treatment.

Lizandra Marcondes, MD, PhD, senior VP Medical Affairs & Drug Safety US, Averitas Pharma, said: "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. We look forward to completing the Clinical Trial with the goal to file a supplemental new drug application to the US Food and Drug Administration (FDA) in 2026, assuming positive data."