- IND for liquid formulation, NGX-1998, expected to be opened and commencement of clinical development expected in second quarter of 2008 - NDA submission for dermal patch, NGX-4010, in PHN expected in second half
- NGX-4010 MAA under EMEA review for peripheral neuropathic pain
SAN MATEO, Calif., May 15 /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 of 2008.
Anthony DiTonno, President and CEO, commented, "We are focused on achieving our overall goal of receiving marketing approval for our lead product candidate, NGX-4010 in the United States and Europe. Following our recent meeting with the U.S. Food and Drug Administration (FDA), we believe that we are on track to file a new drug application (NDA) later this year for the postherpetic neuralgia (PHN) indication. Our marketing authorization application (MAA) was accepted by the European Medicines Agency (EMEA) in September of last year under the centralized procedure. We have been granted an extension for our response to the Day 120 questions in order to include additional clinical data and plan to submit our response in the third quarter of 2008."
Mr. DiTonno continued, "During the second quarter of 2008, we plan to open an investigational new drug (IND) application for our second product candidate, NGX-1998, a liquid formulation of capsaicin, the same active ingredient in our lead product candidate, NGX-4010. We are evaluating our clinical program for NGX-1998 in a range of neuropathic pain conditions."
|SOURCE NeurogesX, Inc.|
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