What is it?

Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin). It contains the active substance capsaicin (8%).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults who do not have diabetes. It can be used alone or together with other painkillers. The medicine can only be obtained with a prescription.

How is it used?

Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor. It is applied to the most painful areas of the skin. The painful area should be determined by a doctor and marked on the skin. Qutenza can only be applied to unbroken, non-irritated, dry skin. Patches can be cut to match the area to cover. No more than four patches should be used on the patient at the same time. Before applying Qutenza, the area must be treated with a local anaesthetic, so that it is numbed; this helps to reduce discomfort. Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body. Once the patch is removed, the area is cleaned using the cleansing gel provided. It may take between one day and two weeks for Qutenza to have an effect. The treatment may be repeated every three months depending on the patient?s symptoms. Qutenza can cause a burning sensation on the skin. Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch.

How does it work?

The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ?selective agonist? of the ?transient receptor potential vanilloid 1? (TRPV1) receptor. This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin. Qutenza contains high doses of capsaicin that are released quickly and overstimulate the TRPV1 receptors. Overstimulating the receptors makes them become ?desensitised? and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain.

How has it been studied?

Qutenza has been 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 of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection). The main measure of effectiveness was the reduction in the 24-hour pain score during the eight or 12 weeks period after application of the patch.

What benefits has it shown during the studies?

Qutenza was more effective at reducing neuropathic pain than the control patches. In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches. In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control. In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.

What is the risk associated?

The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and erythema (redness) at the site of application. 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 ingredients.

Why has it 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 authorisation.

Cookies help us deliver our services. By using our services, you agree to our use of cookies. OK