FDA approves new indication for Grünenthal, Averitas' Qutenza

Patients with neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults will soon have a new medication to treat their condition. The Food and Drug Administration has cleared Grünenthal and its U.S. subsidiary Averitas Pharma’s Qutenza (capsaicin) 8% patch for this new indication.

Qutenza is a topical, non-systemic, non-opioid pain treatment delivered in the form of a patch and is the first and only treatment of its kind to deliver prescription strength capsaicin directly into the skin.

"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 Simpson, principal investigator and professor of neurology at the Icahn School of Medicine at Mount Sinai. "In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments."

"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," said Jan Adams, chief scientific officer for Grünenthal. "This expanded indication of Qutenza in the United States is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide."

Qutenza (capsaicin) 8% patch has been approved for the management of neuropathic pain associated with postherpetic neuralgia since 2009.