A skin patch that delivers an 8% capsaicin formulation intradermally and that first received US Food and Drug Administration approval in 2009 for the treatment of postherpetic pain now has agency approval for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults, according to a company announcement on July 21.
The patch, marketed as Qutenza, is a topical, nonsystemic, nonopioid pain treatment and is “the first and only treatment of its kind to deliver prescription strength capsaicin directly into the skin,” according to Averitas Pharma, which will market the patch in the United States.
“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,” said David M. Simpson, MD, lead investigator of the STEP study that established the patch’s efficacy in this setting. He is professor of neurology at the Icahn School of Medicine at Mount Sinai, New York City.
“In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments,” noted Simpson in the company press release.