What is Qutenza?
Qutenza is a skin patch (a patch that delivers a medicine to the skin), containing the active substance capsaicin (8%).
What is Qutenza used for?
Qutenza is used to treat peripheral neuropathic pain (pain caused by damage to the nerves) in adults without diabetes. It can be used alone or in combination with other pain relievers.
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 is applied to the most painful areas of the epidermis. It is up to a doctor to identify the painful areas, marking them on the skin. Qutenza should be applied to dry, intact and non-irritated skin. The patches can be cut to fit the area. of affected skin. It is not recommended to apply more than four patches to a patient at the same time. Before applying the patch, the skin area should be treated with a local anesthetic to numb it; this helps to reduce discomfort. Qutenza should be applied for 30 minutes if applied to the feet and for 60 minutes if applied to other parts of the foot. After peeling off the patch, clean the area using the cleansing gel provided. It may take a day to two weeks for the Qutenza effect to be felt. The treatment can be repeated every three months depending on the patient's symptoms.
Qutenza can cause a burning sensation on the skin. Healthcare professionals should therefore wear nitrile gloves to apply and remove the patch.
How does Qutenza work?
The active ingredient in Qutenza, capsaicin, is a substance usually contained in chilli that is a "selective agonist" of the "potential transient 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 which are rapidly released and which induce "ultrastimulation of TRPV1 receptors. As a result of 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 St. Anthony's Fire, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (nerve damage caused by the infection). from HIV). The main measure of effectiveness was the reduction in the 24-hour pain index score during the 8 or 12 week period following patch application.
What benefit has Qutenza shown during the studies?
Qutenza was more effective in reducing neuropathic pain than the control patches. In the two studies with patients with postherpetic neuralgia, the reduction in pain index score was 30% and 32% in patients who received Qutenza, compared with 20% and 24% in patients who received the patches. In one of the studies with patients with HIV-associated neuropathy, patients who received Qutenza experienced a 23% reduction in pain index score after 12 weeks, compared with an 11% reduction. in patients who have been given control patches. In the second study with patients with HIV-associated neuropathy, Qutenza was not shown to be more effective than control, although it 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 side effects reported with Qutenza, see the package leaflet.
Qutenza must not be used in people who may be hypersensitive (allergic) to capsaicin or any of the other ingredients.
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 a Marketing Authorization.
What measures are being taken to ensure the safe use of Qutenza?
The company that makes Qutenza intends to ensure that an education plan is available in all Member States for the healthcare 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.
Other information about Qutenza:
On May 15, 2009, the European Commission issued a "Marketing Authorization" for Qutenza, valid throughout the European Union. The holder of the "Marketing Authorization" is Astellas Pharma Europe BV. commerce remains valid for five years, after which it can be renewed.
For the full version of Qutenza's EPAR, click here.
Last update of this summary: 10-2009
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