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FDA NEWS RELEASE

For Immediate Release: Nov. 17, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection.  PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.

Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.

“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.

Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.

The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.

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