Grünenthal presents Phase III results for Qutenza® in post-surgical neuropathic pain at IASP 2026 World Congress on Pain

• Late-breaking data from the Phase III RISE trial further strengthen the well-established efficacy and safety profile of Qutenza^®.
• Post-surgical neuropathic pain is a debilitating complication of surgery affecting millions of patients every year.¹
  
  

Aachen, Germany, 28 October 2026 – Grünenthal, a global leader in pain management and research, today announced new data from the Phase III RISE trial (NCT04967664), evaluating Qutenza^® versus control in people with post-surgical neuropathic pain. These data were shared today as late-breaking poster presentations at the 2026 International Association for the Study of Pain (IASP) World Congress on Pain in Bangkok, Thailand.

The trial (n=409) showed that Qutenza^® achieved a statistically significantly greater reduction in average pain intensity (API) than the control treatment over weeks 2-12, meeting one of its pre-specified primary endpoints. When evaluating API at week 12 specifically, at the point when patients would typically return for retreatment, the numerical difference favoured Qutenza^® but did not reach statistical significance. In the extension phase of the trial, in which up to 4 retreatments were allowed, Qutenza^® achieved a statistically significantly greater reduction in API than the control treatment over weeks 2-42. Safety findings were consistent with previous Qutenza^® trials and no new safety signals were observed. These data support the well-established efficacy and safety profile of Qutenza^®.[2]^,[3]

“Post-surgical neuropathic pain can be difficult to manage with current treatment options, and there is an urgent need for patient-centred, effective solutions. The RISE trial provides encouraging evidence that Qutenza^® can deliver clinically meaningful and sustained pain reduction for up to 42 weeks, having shown a greater reduction in average pain intensity than the control,” said Prof. Patrice Forget, MD, PhD, FFPMRCA, Clinical Chair (full professor) in Anaesthesia, University of Aberdeen, and Honorary Consultant, NHS Grampian, Aberdeen, UK. “As IASP shines a global spotlight on neuropathic pain at this year's congress, findings such as these are important to help improve outcomes for patients and reduce the burden of pain on families and healthcare systems.”

“Post-surgical neuropathic pain has been relatively understudied and continues to go under-recognised in clinical practice,” said Uli Brödl, Chief Scientific Officer, Grünenthal. “These results build on the robust body of evidence for Qutenza^® and reinforce its potential to provide meaningful, long-lasting pain relief for people living with pain.”

Post-surgical neuropathic pain is a poorly recognised potential complication of surgery that can result in devastating outcomes. It affects millions of patients every year, with pain lasting for months or years post-procedure.¹ It can also have a significant mental health impact, with patients reporting feeling extremely depressed or anxious, and having problems with daily activities.[4]

Qutenza^® is already approved in Europe for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain.[5] It is also approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.[6]

 

About the RISE trial ²,³

The RISE (AV-001) trial is a Phase III multi-centre, randomised, double-blind, parallel-group trial to confirm the efficacy and safety of Qutenza 179mg cutaneous patch versus a low-dose capsaicin control patch in people with moderate to severe post-surgical neuropathic pain.

It included eligible adults with a 24-hour average pain intensity (API) score of 4 or more, a pain duration of 6 to 60 months after index surgery and a DN4 (Douleur Neuropathique 4) Interview score of 3 or more.

Participants were randomly assigned to receive treatment with either a 60-minute Qutenza patch (8%) or a low-dose capsaicin control patch (0.04%).

The trial had two primary endpoints:

• Change in 24-hour API from baseline to the average score of the entire period between Week 2 and Week 12.
• Change in 24-hour API from baseline to the average score at Week 12.
  
  

The primary sponsor of the trial is Averitas Pharma, Inc., Grünenthal’s U.S. subsidiary.

 

About post-surgical neuropathic pain
Post-surgical neuropathic pain (PSNP) is defined as chronic pain with neuropathic characteristics that develops or increases after surgery and persists beyond the normal healing process. It is thought to arise, at least in part, from nerve injury and pain sensitisation associated with surgery.⁷

The signs and symptoms of peri- and post-surgical pain can vary based on the person and the severity of the injury caused in surgery. Reported symptoms include pain caused by stimuli that are normally painless (allodynia), abnormally increased sensitivity to pain (hyperalgesia), tingling, numbness, phantom pain and scar pain. ^,[9],[10]

 

About Qutenza^®
In Europe, Qutenza^® (capsaicin) is indicated for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain.⁵

Qutenza^® (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important US safety information is available at www.qutenza.com.^⁶

Qutenza^® is a topical TRPV1 agonist, designed to provide neuropathic pain relief for up to three months through defunctionalisation of nociceptors and nerve fibre regeneration.

About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2025, Grünenthal employed around 4,100 people and achieved revenues of €1.8 billion.

More information: www.grunenthal.com

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References

[1] Gregory P & Settles K. Pract Pain Manag. 2013;13(9):1–6.

[2] Wallace M et al. Efficacy of high-concentration capsaicin patch in post-surgical neuropathic pain (RISE). Presented at the International Association for the Study of Pain World Congress 2026.

[3] Wallace M et al. Safety and tolerability of high-concentration capsaicin patch in post-surgical neuropathic pain (RISE). Presented at the International Association for the Study of Pain World Congress 2026.

[4] Santos MP, Lemos F, Gomes J, Romao JM, Veiga D. Br J Pain 2024;18(1):42–56.

[5] European Medicines Agency. Qutenza 179 mg cutaneous patch SmPC. Available at: https://www.medicines.org.uk/emc/product/573/smpc

[6] US Food and Drug Administration. Qutenza^® Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf

[7] Correl D. F1000Res. 2017;6:1054.

[8] Werner MU & Kongsgaard UE. Br J Anaesth. 2014;113(1):1–4.

[9] Macrae WA. Br J Anaesth. 2008;101:77–86.

[10] Searle RD & Simpson KH. Contin Educ Anaesth Crit Care Pain. 2010;10:12–14.