FDA approves non-opioid capsaicin pain patch for diabetic neuropathy
The FDA approved an 8% capsaicin patch for the treatment of adults with neuropathic pain associated with diabetic peripheral neuropathy of the feet, according to an industry press release.
The patch (Qutenza, Grünenthal and Averitas Pharma) is a topical, non-systemic, non-opioid pain treatment and is the first and only treatment of its kind to deliver prescription strength capsaicin directly into the skin, according to the release.
“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,” David M. Simpson, MD, professor of neurology at the Icahn School of Medicine at Mount Sinai, said in the release. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”
Diabetic neuropathy remains one of the most common chronic complications of both type 1 and type 2 diabetes. According to the National Institute of Neurological Disorders and Stroke, about 60% to 70% of people with diabetes have mild to severe forms of nervous system damage that can affect sensory, motor and autonomic nerves.
“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, chief scientific officer of Grünenthal, said in the release. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”
The capsaicin patch, applied during an in-office procedure, can provide sustained relief that lasts for up to 3 months and has no known drug-drug interactions, according to the release. The most common adverse reactions include application site reactions, such erythema, pain and pruritus. Most application site reactions were transient and self-limited.
The capsaicin 8% patch had been approved in the U.S. for the management of neuropathic pain associated with postherpetic neuralgia since 2009.
Perspective
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The Qutenza patch is a topical delivery system that provides 8% capsaicin, which has previously been shown to be helpful for a number of painful neuropathies of diverse etiology. The patch itself is employed in the outpatient facility by a health care professional, and there are some trials suggesting that it gives some pain relief for up to 3 months. Experience with capsaicin in the management of painful diabetic neuropathy has been variable; most have found it to be particularly helpful in localized pain. Among patients with diffuse pain, perhaps affecting both legs up to the knees and elsewhere, the local patch, in my experience, has been less effective. However, this is a useful addition to the armamentarium for the treatment of painful neuropathy and has only a few local side effects, including some erythema and pain and itching at the site of attachment of the patch.
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