What is Qutenza?
Qutenza is a skin patch (a patch that releases a medicine on the skin), containing the active ingredient capsaicin (8%).
What is Qutenza used for?
Qutenza is used to treat peripheral neuropathic pain (pain caused by nerve damage) in adults without diabetes. It can be used alone or in combination with other painkillers.
The medicine can only be obtained with a prescription.
How is Qutenza used?
The patch should be applied by your doctor or a healthcare professional under the supervision of your doctor. Qutenza applies to the most painful areas of the epidermis. It is up to a doctor to identify the painful areas by marking them on the skin. Qutenza must be applied to dry, intact and non-irritated skin. The patches can be cut to match the affected area of skin. It is not recommended to apply more than four patches to one patient at the same time. Before applying the patch, the skin area must be treated with a local anesthetic to anesthetize it; this helps reduce discomfort. Qutenza must be applied for 30 minutes if applied to the feet and for 60 minutes if applied to other parts of the body. After removing the patch, clean the area using the supplied cleansing gel. It may take from one day to two weeks before the Qutenza effect is felt. Treatment can be repeated every three months depending on the patient's symptoms.
Qutenza can cause a burning sensation on the skin. Professional healthcare professionals should therefore wear nitrile gloves to apply and detach the patch.
How does Qutenza work?
The active ingredient in Qutenza, capsaicin, is a substance usually found in chili peppers which is a "selective agonist" of the "transient potential vanilloid receptor 1" (TRPV1). This means that it stimulates the TRPV1 receptor, found in cutaneous nociceptors (pain receptors) in the skin. Qutenza contains high doses of capsaicin that are released quickly and induce an overstimulation of TRPV1 receptors. Due to excessive stimulation the receptors become "desensitized" and are no longer able to respond to stimuli that normally cause pain in patients with peripheral neuropathic pain.
How has Qutenza been studied?
The effects of Qutenza were compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1, 619 adults with moderate to severe neuropathic pain. All patients had neuropathic pain due to postherpetic neuralgia (pain that occurs in patients with shingles, an infection caused by the varicella zoster virus) or neuropathy associated with HIV (damage to the nerves caused by the infection). from HIV). The main measure of effectiveness was the reduction of the pain index score over 24 hours during the 8 or 12 week period following the application of the patch.
What benefit has Qutenza shown during the studies?
Qutenza was more effective in reducing neuropathic pain than control patches. In the two studies with patients suffering from postherpetic neuralgia, the reduction in the pain index score was 30% and 32% in the patients who received Qutenza, compared to 20% and 24% in the patients who received the patches control. In one of the studies with patients with HIV-associated neuropathy, in patients who received Qutenza, there was a 23% reduction in pain score after 12 weeks, compared to an 11% reduction in patients whose control patches were administered. In the second study with patients suffering from HIV-associated neuropathy, Qutenza has not been shown to be more effective than control, although it has reduced pain by 30%.
What is the risk associated with Qutenza?
The most common side effects seen with Qutenza (seen in more than 1 in 10 patients) are pain and erythema (redness) at the application site. For the full list of all side effects reported with Qutenza, see the Package Leaflet.
Qutenza should not be used in people who may be hypersensitive (allergic) to capsaicin or any of the other components.
Why has Qutenza been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza's benefits are greater than its risks and recommended that Qutenza be given marketing authorization.
What measures are being taken to ensure the safe use of Qutenza?
The company that produces Qutenza intends to make sure that an educational plan is available in all Member States for health professionals who will prescribe Qutenza. This program will contain information on how to administer, manage and dispose of Qutenza as well as warnings and precautions to be observed during treatment.
More information on Qutenza:
On May 15, 2009, the European Commission issued a marketing authorization for Qutenza, valid throughout the European Union. The marketing authorization holder is Astellas Pharma Europe BV The marketing authorization remains valid for five years, after which it may be renewed.
For the full EPAR of Qutenza, click here.
Last update of this summary: 10-2009
