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| |  FDA Approves Capsaicin 8% Patch for Treatment of Postherpetic Neuralgia SAN MATEO, Calif. -- November 16, 2009 -- The US Food and Drug Administration (FDA) has approved capsaicin (Qutenza) 8% patch for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. This is the first approved product containing prescription-strength capsaicin, the substance in chili peppers that gives them their heat sensation. The patch delivers a synthetic form of capsaicin, providing up to 12 weeks of reduced pain following a single 1-hour application. “PHN can be an excruciatingly painful condition that can affect many aspects of a patient’s quality of life. Despite a variety of medications for pain, undesirable side effects often limit their use and, therefore, the treatment of PHN continues to represent a significant unmet need,” said Lynn Webster, MD, Lifetree Clinical Research, Salt Lake City, Utah. “[The capsaicin 8% patch] may provide a unique treatment option that works at the site of the pain and may be useful as a treatment option in combination with existing therapies.” The treatment works by targeting certain pain nerves in the area of skin where pain is being experienced. The patch is applied by a physician or a healthcare professional. Clinical studies have shown that PHN pain can be reduced for up to 12 weeks following a single 1-hour treatment. Up to 4 patches may be used and patches may be cut to conform to the size and shape of the painful area. Capsaicin 8% patch is a locally-acting, non-narcotic medication that is unlikely to cause drowsiness or have drug-drug interactions. Treatment may be repeated every 3 or more months as warranted by the return of pain. In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among treated patients, 1% discontinued prematurely due to an adverse event. Serious adverse reactions included application site pain and increased blood pressure. Increases in blood pressure occurred during or shortly after exposure to the treatment. The changes were on average <10 mm Hg; although, some patients had greater increases and these changes lasted for approximately 2 hours after patch removal. The capsaicin 8% patch also has been approved in the European Union. SOURCE: NeurogesX, Inc.
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