Key Developments For NeurogesX, Inc.
NeurogesX, Inc. (NGSX.O) (Consolidated Issue listed on NASDAQ Global Market)
NeurogesX Inc Receives FDA Approval Of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
NeurogesX Inc announced 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. 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 and patches may be cut to conform to the size and shape of the painful area. Qutenza is a locally-acting, non-narcotic medication that is unlikely to cause drowsiness or have drug-drug interactions. Treatment with Qutenza may be repeated every three or more months as warranted by the return of pain.
NeurogesX Inc Announces New PDUFA Date For Qutenza New Drug Application
NeurogesX Inc announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza to manage pain associated with postherpetic 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. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline.
NeurogesX Inc And Astellas Pharma Inc.'s Astellas Pharma Europe Ltd. Enter Commercialization Agreement For Qutenza
NeurogesX Inc and Astellas Pharma Europe Ltd., (Astellas), the European subsidiary of Astellas Pharma Inc. announced that the companies have entered into an exclusive Distribution, Marketing and License agreement for the commercialization of Qutenza in the European Economic Area (EEA) including the 27 countries of the European Union, Iceland, Norway, and Liechtenstein as well as Switzerland, certain countries in Eastern Europe, the Middle East and Africa. The agreement closely follows the European Commission's approval received in May 2009, of Qutenza (capsaicin 179 mg) cutaneous patch for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal pain products. Under terms of the agreement, Astellas will commercialize Qutenza in the above-mentioned territories and perform certain development of Qutenza including post-marketing commitments, to support Qutenza in the EU market. NeurogesX will receive EUR 30 million (approximately $42 million) for Qutenza commercialization rights, and EUR 5 million (approximately $7 million) for a license option of NGX-1998, the liquid formulation which uses the same active ingredient as Qutenza. NeurogesX is eligible for additional sales-based payments and additional option payments related to the liquid formulation totaling approximately EUR 70 million ($97 million) and royalties based on a double-digit percentage of net sales for Qutenza.
NeurogesX Inc Provides U.S. Regulatory Update For Qutenza
NeurogesX Inc announced that the U.S. Food and Drug Administration (FDA) agreed to its proposed study to evaluate Qutenza in patients with post herpetic neuralgia (PHN) following pretreatment with an FDA approved topical anesthetic. As part of its ongoing new drug application (NDA) review, the FDA wants to determine whether pretreatment with an FDA approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program.
NeurogesX Inc Receives FDA Orphan Drug Designation For Qutenza For Treatment Of Postherpetic Neuralgia
NeurogesX Inc announced that the Office of Orphan Product Development (OOPD) of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Qutenza(formerly NGX-4010), a high concentration capsaicin dermal patch for the management of neuropathic pain in patients with postherpetic neuralgia (PHN).
