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30 March 2021

Grünenthal strengthens QUTENZA brand and seeks further label expansion in the US

Grünenthal’s US subsidiary Averitas Pharma will initiate a Phase III study to prepare a US label extension for the treatment of post-surgical neuropathic pain, a complication of surgery affecting 3.3 million patients per year in the US.1
Grünenthal is taking the next step to make QUTENZA® available to more patients, following the successful US label extension in July 2020 for adults with neuropathic pain associated with diabetic peripheral neuropathy of the feet. Averitas Pharma, Inc., Grünenthals US subsidiary, will conduct a Phase III trial to study the efficacy, safety and tolerability of QUTENZA in post-surgical neuropathic pain (PSNP) with the goal to expand the current product label. The randomised, double-blind trial AV001 will include 400 – 500 patients who have been suffering from moderate to severe PSNP for at least six months. The study aims to demonstrate a significant reduction in the average pain intensity after 12 weeks and 42 weeks compared to the baseline. In addition, it will investigate further aspects such as progressive response over time with repeated application, reduction of the treatment area over several applications, and Quality of Life outcomes including sleep interference, physical activity, anxiety and depression. Trial completion and sNDA submission is expected in 2024 while the first patients are expected to be enrolled in Q3/2021.

“Many patients still do not achieve satisfactory treatment outcomes. Qutenza can offer a meaningful treatment option for this debilitating disease.”

Gabriel Baertschi, CEO Grünenthal

The unmet medical need
Post-surgical neuropathic pain (PSNP) is a debilitating complication of surgery that affects approximately 13 percent of all patients who undergo surgery1 – it’s characterised by burning, stabbing or shooting neuropathic pain. Commonly used oral, systemically acting medicines often provide unsatisfactory results or are accompanied by considerable side effects. QUTENZA, delivering prescription strength capsaicin directly to the skin, may offer a meaningful non-systemic and non-opioid treatment option.
Continuous development of QUTENZA
Grünenthal acquired the exclusive commercial rights for QUTENZA in Europe, the Middle East and Africa in December 2016 and became the sole owner of the product in November 2018. In July 2020, Grünenthal and Averitas Pharma significantly expanded the reach of QUTENZA in the US by expanding the label to include the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. This complication of diabetes affected more than 5 million Americans in 20202, and the number of affected patients is expected to double by 20303.
1

Classifying surgeries were factored against their respective time-bound frequency of PSNP to yield the prevalence based on:
- Carroll, I. R., Hah, J. M., Barelka, P. L., Wang, C. K. M., Wang, B. M., Gillespie, M. J., … Mackey, S. C. (2015). Pain Duration and Resolution following Surgery: An Inception Cohort Study. Pain Medicine, 16(12), 2386–2396. doi:10.1111/pme.12842.
- Shipton, E. (2008). POST-SURGICAL NEUROPATHIC PAIN. ANZ Journal of Surgery, 78(7), 548–555. doi:10.1111/j.1445-2197.2008.04569.x
- Borsook, D., Kussman, B. D., George, E., Becerra, L. R., & Burke, D. W. (2013). Surgically Induced Neuropathic Pain. Annals of Surgery, 257(3), 403–412. doi:10.1097/sla.0b013e3182701a7b.

2

LTP 2020-2030: Addressable populations by condition (PDPN, PSNP, PHN, CINP). Company data on file. April 30, 2020.

3

Gore, M., Brandenburg, N. A., Dukes, E., Hoffman, D. L., Tai, K.-S., & Stacey, B. (2005). Pain Severity in Diabetic Peripheral Neuropathy is Associated with Patient Functioning, Symptom Levels of Anxiety and Depression, and Sleep. Journal of Pain and Symptom Management, 30(4), 374-385. doi:10.1016/j.jpainsymman.2005.04.009
https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html.

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