Grünenthal Unveils Phase III RISE Trial Results for Qutenza® in Post-Surgical Neuropathic Pain Management
Grünenthal Unveils Phase III Results for Qutenza®
Grünenthal, a prominent player in pain management, recently presented groundbreaking findings from the Phase III RISE trial concerning Qutenza®, a treatment aimed at alleviating post-surgical neuropathic pain. This update was unveiled as a recent poster presentation during the 2026 World Congress on Pain in Bangkok, Thailand, emphasizing the company’s commitment to advancing pain management solutions.
Understanding Post-Surgical Neuropathic Pain
Post-surgical neuropathic pain (PSNP) is a challenging condition that often develops after surgical procedures, leading to long-lasting discomfort affecting millions of patients annually. This type of pain can severely impact patients' mental health, as research indicates that many experience significant levels of depression and anxiety alongside their physical pain.
In its Phase III RISE trial, Grünenthal enrolled 409 patients suffering from moderate to severe PSNP. The trial compared the efficacy of Qutenza® against a low-dose capsaicin control patch. The primary endpoints were the change in average pain intensity (API) both at weeks 2-12 and week 12 specifically, marking the point where most patients seek retreatment.
Trial Results
The findings revealed that Qutenza® achieved a statistically significant reduction in pain intensity compared to the control treatment during the specified weeks. Notably, during the 12-week evaluation, a larger numerical reduction in API was observed with Qutenza®, bolstering its status as a viable treatment option. In the trial’s extension phase, where participants could receive up to four retreatments, Qutenza® showed even more pronounced benefits, effectively reducing pain over a longer time frame.
Prof. Patrice Forget, Clinical Chair of Anaesthesia at the University of Aberdeen, highlighted the significance of these results, stating, “Post-surgical neuropathic pain necessitates effective, patient-centered solutions. The RISE trial's results show that Qutenza® can deliver significant and sustained pain relief.”
Safety Profile
Safety evaluations from the RISE trial indicated findings aligned with those of previous Qutenza® studies. Notably, no new safety concerns were reported, reinforcing the drug's established safety profile in treating neuropathic pain. These insights are invaluable as they shed light on the drug's potential to address a critically underserved patient demographic struggling with chronic pain conditions.
Broader Implications
The implications of the RISE trial results extend beyond immediate pain relief. They indicate the potential for improved healthcare outcomes by introducing innovative treatment options that address the multifaceted aspects of post-surgical pain. Uli Brödl, the Chief Scientific Officer at Grünenthal, remarked, “Post-surgical neuropathic pain has historically been under-researched. The RISE trial findings enhance the evidence base for Qutenza®, creating hope for those enduring debilitating pain following surgery.”
Conclusion
With Qutenza® currently approved across Europe and the U.S. for various neuropathic pain indications, these new results may pave the way for expanded applications in treating PSNP. Grünenthal remains committed to innovation in pain management, striving towards a future where effective solutions are readily accessible to those in need.
This successful presentation at the IASP congress not only emphasizes Qutenza®'s effectiveness but also raises awareness about the broader implications of post-surgical neuropathic pain as a serious healthcare issue that demands recognition and new therapeutic strategies.