NeurogesX Receives FDA Approval of Qutenza(TM) (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

SAN MATEO, Calif., Nov. 16 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX - News) announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. It is the first product from NeurogesX to be approved by the FDA. "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, M.D., Medical Director, Lifetree Clinical Research, Salt Lake City, Utah. "Qutenza 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."Qutenza works by targeting certain pain nerves in the area of skin where pain is being experienced. The Qutenza 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 one-hour treatment. Up to four patches may be used ...
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NeurogesX gets FDA approval for pain patch

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NeurogesX pain patch gets FDA OK

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Fda Approves Qutenza(TM), First and Only Prescription Strength Capsaicin Product for Pain Reduction

The U.S. Food and Drug Administration (FDA) has approved Qutenza, a new prescription patch applied to the skin for one hour for reduction of post-shingles nerve pain. Qutenza is the first and only prescription strength capsaicin product. Qutenza contains a manmade form of capsaicin, the substance in chili peppers that gives them their heat sensation. After a single one-hour application, directly to the site of pain, Qutenza may reduce post shingles nerve pain for up to 12 weeks. Qutenza is applied by a doctor or healthcare professional. Qutenza can be used alone or with other pain medications and is unlikely to cause drug-drug interactions.* Each year, about a million Americans develop shingles, a painful virus infection related to chicken pox.* Up to one in five people with shingles will experience prolonged pain due to a complication called postherpetic neuralgia (PHN).o PHN is a chronic condition that is the result of nerve damage caused by the shingles virus.o The pain can persist long after the characteristic rash clears up and can disrupt sleep, mood, work and activities of daily living.o The risk of developing PHN increases with age, especially in people over 50, and for patients who experienced severe pain or severe rash during the acute shingles episode. Please see full prescribing information at www.qutenza.com. SATELLITE FEEDS: Monday, November 16th, 2009 Tuesday, November 17th, 2009 7:30 PM - 7:45 PM ET 3:00 AM - 3:15 AM ET Galaxy 19 Galaxy 19 C-Band C-Band Transponder 20 Transponder...
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NeurogesX to Hold Conference Call to Discuss FDA Approval of Qutenza(TM) (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

SAN MATEO, Calif., Nov. 17 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX - News) announces that it will hold a conference call today at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at www.neurogesx.com.A replay of the conference call will be available beginning November 17, 2009 at 11:30 a.m. ET (8:30 a.m. PT) and ending on December 17, 2009 by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 338031. A replay of the webcast will also be available on the corporate website for one month, through December 17, 2009.About Qutenza Qutenza(TM) (capsaicin) 8% patch is a 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. T...
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Early-Market Movers: Semitool, Cerus

Stock futures were pointing to a lower opening as the Street digests a slew or earnings from retailers.    Here are some of the early-market movers for Tuesday.  Semitool Inc. (SMTL)  Shares of the semiconductor-manufacturing equipment company jumped 30% in pre-market trading after announcing it would be acquired by Applied Materials Inc. (AMAT) in a $11 per share $364 million cash deal by the end of the year.  NeurogesX Inc. (NGSX)  The biopharmaceutical company announced its pain treatment, Qutenza, was approved by the FDA to treat nerve pain resulting from an outbreak of shingles. Shares gained 16% in pre-market trading on the news.  BluePhoenix Solutions (BPHX)  The technology modernization services company announced it was awarded a multi-million dollarcontract from IBM (IBM) to update and integrate IBM’s disparate legacy purchase order systems. BluePhoenix shares were up 8.4% in pre-market trading.  Pacific Sunwear of California Inc (PSUN)  Despite posting a narrower loss than expected after the bell Monday for the third-quarter, shares of the retailer were down 21.3% in pre-market trading Tuesday. The company reported a loss of 17 cents per share versus analyst estimates of a loss of 20 cents per share but lowered fourth quarter guidance below current expectations.  ...
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NeurogesX shares rise following FDA approval

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NEUROGESX INC Files SEC form 8-K, Other Events, Financial Statements and Exhibits

Show all filings for NEUROGESX INC | Request a Trial to NEW EDGAR Online Pro Form 8-K for NEUROGESX INC 17-Nov-2009Other Events, Financial Statements and Exhibits Copyright © 2009 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service - Copyright/IP Policy - Send Feedback SEC Filing data and information provided by EDGAR Online, Inc. (1-800-416-6651). All information provided "as is" for informational purposes on...
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