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23 July 2020

The FDA has approved Qutenza® for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults

Successful US label extension for Qutenza

The US Food & Drug Administration (FDA) has approved Qutenza® (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.¹ It is estimated that more than 5 million patients will suffer from this condition in the US this year², and the number is expected to double by 2030.³

“The label extension for Qutenza® is an exciting moment in our efforts to reach more patients in need.”

Jan Adams,

Chief Scientific Officer, Grünenthal

Qutenza® (capsaicin) 8% patch has been approved in the U.S. for the management of neuropathic pain associated with postherpetic neuralgia since 2009 – and we’re committed to make Qutenza® available for even more patients to serve their unmet medical needs. The recent FDA approval of Qutenza® for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults is a key milestone on this journey. It’ll enable us to reach even more patients with Qutenza® and moves us another step closer towards bringing to life our ambitious vision of a world free of pain.

Painful Diabetic Peripheral Neuropathy, commonly known as diabetic nerve pain, is a complication of diabetes that can have a severe impact on patients’ quality of life. People with this condition typically experience numbness or tingling, as well as shooting or stabbing sensations in their feet. On top of this, patients experience high levels of anxiety and/or depression, as well as disrupted sleep. It is estimated that 5 million people in the US will be affected by this condition in 2020², and this figure is expected to double by 2030³. However, many patients are unable to get effective pain relief from available treatments. This translates into a relevant number of patients still experiencing a high unmet medical need due to sub-optimal DPN pain management that we can now help address with Qutenza®.

Qutenza® is a topical, non-systemic, non-opioid pain treatment in the form of a patch. It delivers prescription-strength capsaicin – the substance that gives chili peppers their heat – directly into the skin during an procedure in a doctor’s office. The treatment may provide pain relief for up to three months. Qutenza® can offer adult patients suffering from diabetic peripheral neuropathy of the feet a new treatment option in the US that has no known drug-drug interactions. The most common adverse reactions include application site reactions, such erythema, pain, and pruritus. The majority of application site reactions were transient and self-limited.¹

About Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

More than 34 million Americans – just over 1 in 10 – have diabetes⁵, and diabetic peripheral neuropathy, or nerve damage caused by diabetes, is one of its most common complications.⁶ Diabetic peripheral neuropathy (DPN) affects around 28% of all patients diagnosed with diabetes and approximately half of those with DPN will experience the debilitating manifestations of painful DPN in their lifetime.^{7,8,9,10,11,12,13} It is a progressive and debilitating condition in which patients experience symptoms of numbness, tingling, as well as shooting or stabbing sensations that most often affects the lower extremities.⁷ Its consequences can be devastating and may result in foot ulcers, lower limb amputations and other poor outcomes.⁴ In the U.S., one fourth of the health expenditure on diabetes is spent on diabetic peripheral neuropathy and is estimated to be more than $10 billion annually.^7,14,15

About Qutenza®

Qutenza® (capsaicin) 8% patch 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. A single localized procedure with Qutenza® may provide up to 3 months of relief. Important U.S. safety information are available at www.qutenza.com

Qutenza® is also approved in Europe. For further information please visit www.grunenthalhealth.com

¹ QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma

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.

⁴ Vinik, Aaron I., et al. Repeat treatment with capsaicin 8% patch (179mg capsaicin cutaneous patch): Effects on pain, quality of life, and patient satisfaction in painful diabetic peripheral neuropathy: an open-label, randomized controlled clinical trial; Journal of Current Medical Research and Opinion 2.12 (2019): 388-401.

⁵ CDC Division of Diabetes Translation, National Diabetes Statistics Report, 2020. https://www.cdc.gov/diabetes/library/features/diabetes-stat-report.html#:~:text=New%20in%202020%2C%20the%20report,1%20in%203%E2%80%94have%20prediabetes. Accessed July 6, 2020.

⁶ University of Chicago Center for Peripheral Neuropathy. Types of Peripheral Neuropathy. http://peripheralneuropathycenter.uchicago.edu/learnaboutpn/typesofpn/diabetes/diabetes.shtml. Accessed July 6, 2020.

⁷ Hicks, C. W., & Selvin, E. (2019). Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Current diabetes reports, 19(10), 86. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6755905/#!po=48.3333. Accessed July 6, 2020.

⁸ Iqbal, Z., et al. (2018). Clinical Therapeutics, 40(6), 828–849. doi:10.1016/j.clinthera.2018.04.001.

⁹ Sadosky, A., et al. (2013). Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 79. doi:10.2147/dmso.s37415.

¹⁰ Boulton, A. J. M. (2005). Management of Diabetic Peripheral Neuropathy. Clinical Diabetes, 23(1), 9–15. doi:10.2337/diaclin.23.1.9.

¹¹ Franklin, G. et. al. (1990). American Journal of Epidemiology, 131(4), 633–643. doi:10.1093/oxfordjournals.aje.a115547.

¹² Boomershine, C., Ormseth, M. J., & Scholz, B. A. (2011). Patient Preference and Adherence, 343. doi:10.2147/ppa.s16358.

¹³ Young, M. J., et al (1993). Diabetologia, 36(2), 150–154. doi:10.1007/bf00400697.

¹⁴ Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care, 41(5), 917–928. doi:10.2337/dci18-0007.

¹⁵ Gordois, A., Scuffham, P., Shearer, A., Oglesby, A., & Tobian, J. A. (2003). The Health Care Costs of Diabetic Peripheral Neuropathy in the U.S. Diabetes Care, 26(6), 1790–1795. doi:10.2337/diacare.26.6.1790.

Pain, Access to healthcare, Patients