The study involves 410 patients who were experiencing moderate to severe PSNP for a minimum of six months. Credit: Chinnapong/Shutterstock.

Averitas Pharma, the US subsidiary of Grünenthal, has completed patient recruitment for the Phase III AV001 clinical study, which is assessing QUTENZA (capsaicin) 8% topical system to treat post-surgical neuropathic pain (PSNP).

It will assess the safety, efficacy and tolerability of the treatment.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

The double-blind, randomised trial spans 42 weeks and includes 410 patients who were experiencing moderate to severe PSNP for a minimum of six months.

Its primary endpoint is a decrease in average pain intensity at the 12-week mark compared to the baseline measurements.

The successful completion of this trial could lead to an expanded indication for QUTENZA in the US market.

Averitas Pharma president Marv Kelly said: “The completion of enrolment is an exciting milestone. With our current indications, adults with painful diabetic peripheral neuropathy of the feet and postherpetic neuralgia, we have advanced the trajectory of QUTENZA in the US by expanding access to a much-needed non-opioid therapy option for a large, underserved patient population.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.”

The study also evaluates several other results, including a 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 such as anxiety and depression.

AV001 is set to be the inaugural blinded randomised controlled trial in PSNP that analyses the long-term effects of topical neuropathic pain treatment.

Through this trial, Grünenthal and Averitas Pharma aim to add another significant indication for peripheral neuropathic pain to the US label of Qutenza.

The trial’s topline outcomes are expected in the fourth quarter of 2025.

After acquiring the US rights to Qutenza in 2018, Grünenthal re-launched the product, which initially was approved for treating neuropathic pain associated with postherpetic neuralgia.

In 2020, the US Food and Drug Administration (FDA) granted approval to Qutenza for treating neuropathic pain related to diabetic peripheral neuropathy (DPN) of the feet in adults.

Assuming positive trial data, Averitas Pharma plans the submission of a supplemental new drug application (sNDA) in 2026.