Manufacturer:

NeurogesX, Inc.

Pharmacological Class:

TRPV1 channel agonist

Active Ingredient(s):

Capsaicin 8% (179mg); patch.

Indication(s):

Management of neuropathic pain associated with post-herpetic neuralgia.

Pharmacology:

After an attack of shingles, nerve pain (post-herpetic neuralgia) can persist long after resolution of the rash. As a result of damage caused by the herpes zoster virus, nerves can transmit sensations such as burning, tingling, shooting or sharp pain, or numbness. Qutenza is a localized application patch containing prescription strength capsaicin, a synthetic equivalent of a substance found in chili peppers. Capsaicin activates certain pain receptors found in dermal nerve endings. This receptor type, the transient receptor potential vanilloid 1 receptor (TRPV1), is initially stimulated by capsaicin. Pain relief occurs after what is thought to be a reduction in TRPV1-expressing nociceptive nerve endings.

Clinical Trials:

Two 12-week, double-blind, randomized multicenter studies were conducted to assess the safety and efficacy of Qutenza. Patients had post-herpetic neuralgia persisting for at least 6 months and a baseline pain score of 3 to 9 on an 11-point scale (0=no pain and 10=worst possible pain). The baseline mean pain score across the two studies was approximately 6.

In both studies, the Qutenza group demonstrated a greater reduction in pain compared to the control group during the primary assessment at week 8. In the first study, the percent change in average pain from baseline to week 8 was –18% for the control group compared to –29% for the Qutenza group. In the second study, the percent change in average pain from baseline to week 8 was –26% for the control group compared to –33% for those given Qutenza. Some patients experienced a reduction in pain in the first week that persisted throughout the study. This single, 1 hour localized treatment can provide 3 months of relief from pain associated with post-herpetic neuralgia.

Legal Classification:

Rx

Adults:

Identify treatment area and mark the skin; may cut patches to match size and shape of area. Pretreat with topical anesthetic to reduce discomfort, once anesthetized, remove anesthetic and wash the treatment area. Apply to dry, intact skin within 2 hours of opening patch. Apply patch (up to 4 may be used) for 60 minutes, repeat every 3 months or as warranted by the return of pain (not more frequently than every 3 months). May use a dressing to ensure patch remains in contact with treatment area. After removal of patch, apply Cleansing Gel to area and leave on for at least one minute. Remove Cleansing Gel with dry wipe; wash and dry the area. Treat acute pain during and following the procedure with local cooling and/or analgesics. Use nitrile gloves when handling patch and cleaning capsaicin residue from skin. Immediately dispose of patches.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Should only be administered by a physician or healthcare professional. Aerosolization of capsaicin may occur with rapid removal of patches, remove patches slowly by rolling the adhesive side inward. Avoid exposure to eyes, mucous membranes. Evaluate for recent history of cardio- and cerebrovascular disease. Monitor BP periodically during treatment. Pregnancy (Cat.B). Nursing mothers; do not breastfeed after treatment on the day of treatment.

Adverse Reaction(s):

Application site reactions (eg, erythema, pain, pruritus, papules); increased blood pressure.

How Supplied:

Patch—1, 2 (both with 50g tube of Cleansing Gel)