Conference Call Scheduled Today at 4:30pm ET
European Commission Decision on Qutenza(TM) Expected in 1H 2009
Company to Provide Update on FDA review of Qutenza During Conference Call Today
- CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain
Upcoming 2009 Milestones:
- European Commission decision on MAA for Qutenza anticipated first half of 2009
- European commercial partnership for Qutenza targeted first half of 2009
- FDA PDUFA date of August 16, 2009 for Qutenza NDA to manage pain associated with PHN
SAN MATEO, Calif., May 7 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the first quarter ended March 31, 2009 and provided an update on recent developments.
During the first quarter of 2009, NeurogesX continued to focus on seeking regulatory approvals and on pre-commercialization activities for its lead product candidate Qutenza (formerly NGX-4010). On March 19, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of the marketing authorization application (MAA) for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The CHMP's recommendation for the MAA, filed under the centralized procedure, is
|SOURCE NeurogesX, Inc.|
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