Qutenza (capsaicin patch, 8%) has been approved by the FDA as a treatment for postherpetic neuralgia (post-shingles nerve pain, or PHN). Capsicum information based on scientific evidence includes description, drug interactions, safety concerns, and effectiveness. Pepper Patch for Shingles. July 1, 2009 3:19:04 PM PDT. DATE -- It stems from the same virus that causes chicken pox. Decades later, it appears as a painful rash and blisters. It stems from the same virus that causes chicken pox. Decades later, it appears as a painful rash and blisters. Nearly one million Americans receive medical care for shingles or its complications every year. Shingles and post-herpetic neuralgia. Answer to a readers' question about cayenne pepper used to treat shingles. Apply a little initially to the inside of the forearm as a test patch. Managing Pain from Shingles. Published on August 29, 2011. For Immediate Release: Nov. Media Inquiries: Karen Riley, 301-796-4674; [email protected] Consumer Inquiries: 888-INFO-FDA. FDA Approves New Drug Treatment for Long-Term Pain Relief. Qutenza(R) (capsaicin) 8% Patch for Treatment of Post- Shingles Pain Now Available. SAN MATEO, Calif., April 5 /PRNewswire- First. Call/ - - Neuroges. X, Inc. Clinical studies have shown that a single one- hour Qutenza application can provide three months relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles. In November 2. 00. Qutenza was approved by the U. S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with PHN. Qutenza, the first product from Neuroges. X, is now available through selected specialty distributors and a specialty pharmacy - - a complete list of these distributors is available at www. Qutenza. com. Qutenza is the first prescription- strength topical treatment for PHN to be approved by the FDA in more than 1. Qutenza harnesses the power of capsaicin in a dermal delivery system that targets the nerves in the skin. It is locally- acting and non- narcotic, and unlikely to cause drowsiness or interact with other drugs. Qutenza can be used alone or with other pain medications. It is estimated that up to one in five people with shingles will experience prolonged pain after shingles, known as PHN. The pain can persist long after the shingles rash clears up and can disrupt sleep, mood, work and the activities of daily living. Because of these limitations, there is still a need for new treatment options for PHN, and, more importantly, many patients are still suffering. Qutenza may provide a unique treatment option for patients. It is targeted directly to the site of the pain and may be used alone or in combination with existing therapies. Qutenza gave me relief, and I was grateful for the treatment. Qutenza is applied directly to the painful site by a physician or health care professional under the close supervision of a physician. Qutenza, which can provide patients with three months of pain relief, bears witness to the efficacy of capsaicin and the culmination of 1. PHN patients. Treatment with Qutenza may be repeated every three or more months as warranted by the return of pain, but not more frequently than every three months. In clinical trials, the most common side effects were application- site redness, pain, itching, and papules (small bumps). The majority of these reactions were local, transient and self limited. Among patients treated with Qutenza, 1 percent 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 Qutenza and were associated with treatment- related increases in pain. The changes were on average less than 1. Hg, although some patients had greater increases, and these changes lasted for approximately two hours after patch removal. Neuroges. X is encouraging in- person, educational in- service training for health care professionals interested in prescribing and administering Qutenza for patients with PHN. Training will be provided by clinical educators who offer in- service demonstrations and answer any questions the physician or health care professional may have. Educational training for health care professionals is available online and on DVD through www. Qutenza. com or 8. YOU- LRNQ (5. 76. About Postherpetic Neuralgia (PHN)Postherpetic neuralgia (PHN) is nerve pain that occurs following an attack of shingles. Shingles can damage nerves, and the pain from damaged nerves may feel like a sharp, burning, tingling, shooting sensation or numbness. The pain from PHN can persist long after the shingles rash clears up and can disrupt sleep, mood, work and activities of daily living. The risk of developing PHN increases with age (especially in people over 6. About Qutenza. Qutenza (capsaicin) 8% patch is a localized, dermal delivery system that contains a prescription strength of capsaicin approved in the United States for the management of PHN. Qutenza is designed to reduce the pain associated with PHN after a single one- hour administration. The capsaicin in Qutenza is a synthetic equivalent of a naturally occurring compound found in chili peppers. Please see the complete Prescribing Information and visit the Qutenza Web site at www. Qutenza. com. About Neuroges. X, Inc. Neuroges. X, Inc. Neuroges. X was founded on the concept that use of prescription- strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, Neuroges. X has leveraged its passion to help people with pain to efficiently develop this concept and is now poised to bring its lead product to patients and physicians. In addition, we continue to apply our knowledge and expertise in the development of other novel treatments for pain. The Company's lead product, Qutenza. Qutenza is now available in the United States for patients with postherpetic neuralgia (PHN). In Europe, Qutenza will be marketed by Astellas Pharma Europe Ltd. NGX- 1. 99. 8 has completed three Phase 1 studies. The Company's early- stage product pipeline includes pre- clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated these compounds in vitro and in vivo. Safe Harbor Statement. This press release contains forward- looking statements for purposes of the Private Securities Litigation Reform Act of 1. Neuroges. X disclaims any intent or obligation to update these forward- looking statements, and claims the protection of the Safe Harbor for forward- looking statements contained in the Act. Examples of such statements include but are not limited to: statements about the safety and efficacy of Qutenza. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: difficulties or delays in the commercialization of Qutenza, including with respect to manufacture and supply of Qutenza; Qutenza and Neuroges. X's other product candidates may have unexpected adverse side effects; physician or patient reluctance to use Qutenza; and other difficulties or delays in the launch of Qutenza in the United States. For further information regarding these and other risks related to Neuroges. X's business, investors should consult Neuroges. X's filings with the Securities and Exchange Commission. SOURCE Neuroges. X, Inc.
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