|NeurogesX (NASDAQ: NGSX) Receives FDA Approval for Qutenza|
|Monday, 16 November 2009 17:56|
On 11/16/09, the FDA approved Qutenza (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.
On 8/5/09, NGSX announced that the FDA extended the PDUFA action date by three months to 11/16/09 for the Company's pending new drug application (NDA) for Qutenza which is seeking approval to manage pain associated with post-herpetic neuralgia (PHN). The extension resulted from the Company's recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment.
On 7/24/09, NGSX announced preliminary results of Study C123, which evaluated Qutenza in patients with PHN following pre-treatment with an FDA approved topical anesthetic. NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.
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