Qutenza becomes the first topical treatment with a TRPV1 agonist indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Jan Adams, MD
Grunethal, and its US subsidiary Averitas Pharma, announced that the FDA has approved capsaicin 8% patch (Qutenza) for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.1 It marks the second approval for Qutenza, which received the green light in 2009 for the management of neuropathic pain associated with postherpetic neuralgia.
The treatment is a topical, non-systemic, non-opioid pain therapy 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. Delivered at an in-office procedure, the agent reversibly desensitizes and defunctionalizes the Transient Receptor Potential Vanilloid (TRPV1) receptor, which plays a critical role in pain signaling.
"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, MD, chief scientific officer, Grünenthal, said in a statement. "This expanded indication of Qutenza in the US is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide."
The efficacy of Qutenza was established in 2, 12-week, double-blind, randomized, dose-controlled multicenter clinical trials. In the 12-week PHN Study 1, the Qutenza group demonstrated a greater reduction in pain compared to the control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was —18% (±2%) for the low-dose control and –29% (±2%) for Qutenza. The PHN Study 2 demonstrated similar reduction in patient, with a –26% (±2%) percent change in average pain from baseline to Week 8 for the low-dose control and –33% (±2%) change for the Qutenza group.
Qutenza has no known drug-drug interactions and the most common adverse reactions included application site reactions, such erythema, pain, and pruritus. The majority of the application site reactions were seen as transient and self-limited.2
Only physicians or health care professionals under the close supervision of a physician are able to administer Qutenza and must be done in a well-ventilated treatment area. Additionally, physicians must wear nitrile, not latex, gloves when handling Qutenza and when cleaning treatment areas. It is not intended for use on broken skin.
Those with DPN may apply up to 4 patches for 30 minutes on the feet. Each patch contains 8% capsaicin (640 mcg per cm2), with a total of 179 mg of capsaicin. There are no contraindications associated with Qutenza.
Warnings and precautions include severe irritation of eyes, mucous membranes, respiratory tract, and skin due to unintended capsaicin exposure. Physicians are instructed to remove the affected individual from the vicinity of Qutenza and flush the mucous membranes or eyes with water if irritation of the eyes or airways occur. Additionally, patients may apply Cleansing Gel if skin not intended to treat comes in contact with Qutenza.
Averitas announced on December 18, 2019, that the FDA had accepted its supplemental new drug application (sNDA). Qutenza was originally approved in 2009 for the management of neuropathic pain associated with postherpetic neuralgia.3
1. Grunenthal and Averitas Pharma announce US FDA approval of Qutenza for the treatment of neurpathic pain associated with diabetic peripheral neuropathy of the feet (news release). Aachen, Germany and Morristown, NJ: Grunenthal Group. July 21, 2020. Accessed August 19, 2020. https://www.prnewswire.com/news-releases/grunenthal-and-averitas-pharma-announce-us-fda-approval-of-qutenza-for-the-treatment-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy-of-the-feet-301097209.html
2. Highlights of prescribing information. Qutenza. https://www.qutenza.com/pdfs/Qutenza_Prescribing_Information.pdf. Updated July 20, 2020. Accessed August 19, 2020.
3. Averitas Pharma announces FDA acceptance of sNDA filing for Qutenza (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Morristown, NJ: Grunenthal Group. December 18, 2019. Accessed August 19, 2020. https://www.prnewswire.com/news-releases/averitas-pharma-announces-fda-acceptance-of-snda-filing-for-qutenza-capsaicin-8-patch-for-the-treatment-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy-300976908.html