Diabetic neuropathy — nerve damage in your extremities (arms, legs, hands, and feet) caused by elevated blood glucose levels — can be a frustrating condition to treat. Many of the oral drugs, including opioids, that may be effective at treating this type of pain have major risks or side effects. And topical ointments or creams may be ineffective or offer only slight pain relief.
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So the approval by the U.S. Food and Drug Administration (FDA) of a new pain-relief patch to treat diabetic neuropathy comes as a welcome development for many doctors and patients. The patch, which is sold under the brand name Qutenza, contains 8% capsaicin — a chemical compound derived from chili peppers that gives them their “hotness.” Capsaicin has long been used in topical ointments for pain relief, including sometimes for diabetic neuropathy. But the new approval is the first for a patch that uses this active compound to treat neuropathy, which may offer several benefits over a cream or ointment.
Developed by Grünenthal and sold by its U.S. subsidiary Averitas Pharma in the United States, Qutenza is the first local, non-opioid pain treatment that delivers prescription-strength capsaicin directly to the skin, according to a press release from the company. Capsaicin is one of the few compounds that has been shown to offer effective topical pain relief for diabetic neuropathy, but many ointments contain a much lower concentration of this ingredient than the new patch — making them potentially less effective and their pain relief shorter-lasting.
According to the press release, Qutenza is applied directly to the skin in a procedure in your doctor’s office. It has been shown to “reversibly desensitize and defunctionalize the TRPV1 (Transient Receptor Potential Vanilloid 1) receptor,” which plays a role in pain signaling. The patch can remain effective for up to 3 months, and there are no known drug interactions with the new treatment. Some people experienced a reaction at the applications site, but in most cases, these reactions didn’t last for long and went away on their own.
Qutenza has already been approved and is being used as a treatment for diabetic neuropathy in Europe.
“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” notes David M. Simpson, MD, principal investigator of the studies used for Qutenza’s new FDA approval and professor of neurology at the Icahn School of Medicine at Mount Sinai, in the press release. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”
At least 5 million people in the United States have diabetic neuropathy, according to the press release. That number is expected to double by 2030, due to higher number of people expected to be living with diabetes for a longer duration. The current number represents about 28% of people with diagnosed diabetes.
About half of all people with diabetic neuropathy can be expected to experience debilitating pain at some point in time as a result. Diabetic neuropathy tends to be a progressive condition — meaning that it gets worse over time — that causes symptoms like numbness, tingling or shooting or stabbing sensations, most commonly in the legs and feet, the press release notes. The loss of sensation that may accompany diabetic neuropathy puts many people with diabetes at an increased risk for injuring their foot without knowing it, which can lead to foot ulcers and their complications — including the risk of requiring amputation of toes, feet or legs.
Diabetic neuropathy is also costly to treat, currently accounting for about 25% of all health expenditures related to diabetes in the United States, according to Averitas Pharma.