German pharmaceutical firm Grünenthal, through its US subsidiary Averitas Pharma, has received the US Food and Drug Administration (FDA) approval for QUTENZA (capsaicin) 8% patch to treat a type of neuropathic pain.
The FDA approval indicated QUTENZA for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adult patients.
QUTENZA is a topical, non-systemic, non-opioid pain treatment delivered through a patch and is said to be the first and only treatment to deliver prescription-strength capsaicin directly into the skin.
The drug delivery patch was previously granted US approval in 2009, for the management of neuropathic pain associated with postherpetic neuralgia.
Grünenthal chief scientific officer Jan Adams said: “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.
“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.”
QUTENZA is a patch that delivers prescription-strength capsaicin directly to the skin
Neuropathic pain associated with DPN is a progressive complication of diabetes that results in symptoms of numbness, tingling, along with shooting or stabbing sensations in patients.
The company said that its QUTENZA is specially formulated patch, delivers prescription-strength capsaicin directly to the skin during an in-office procedure, and provides physicians with an alternative way to treat neuropathic pain associated with diabetic peripheral neuropathy.
In addition, the patch works by reversibly desensitising and defunctionalising the transient receptor potential vanilloid 1 (TRPV1) receptor, which plays an important role in pain signalling.
QUTENZA has been designed to provide sustained delivery for up to three months, without causing any known drug-drug interactions, said the company.
Reactions at the application site, including erythema, pain, and pruritus form the most common adverse reactions, and most of the application site reactions were transient and self-limited.
