Third Quarter 2008 Corporate Highlights: * Submitted NDA with FDA for NGX-4010 for management of pain associated
with PHN * Responded to EMEA's scheduled Day 120 questions regarding MAA under
review for NGX-4010 in peripheral neuropathic pain
SAN MATEO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the quarter ended September 30, 2008.
During the third quarter, NeurogesX made significant progress on the regulatory front and continued pre-commercialization activities to support the potential marketing approvals and launch of NGX-4010. In October 2008, the new drug application (NDA) for NGX-4010 for the management of pain associated with postherpetic neuralgia (PHN) was submitted on schedule to the FDA. In September 2008, the Company submitted its response to the European Medicines Agency's (EMEA) scheduled Day 120 questions regarding the marketing authorization application (MAA) for NGX-4010. The MAA, filed under the centralized procedure, is currently under EMEA review for peripheral neuropathic pain.
Anthony DiTonno, President and CEO, commented, "NeurogesX is dedicated
to advancing all activities necessary to support the potential marketing
approvals of NGX-4010 in both Europe and the United States. We are thrilled
with the progress we've made in the past two months with the submission of
our NDA to the FDA for NGX-4010 for the management of pain associated with
PHN, and the submission of our response to the EMEA's scheduled Day 120
questions regarding our MAA for peripheral neuropathic pain.
|SOURCE NeurogesX, Inc.|
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