NeurogesX Announces Preliminary Results From Second Phase 3 Clinical Trial In HIV DSP Part 2
Anthony DiTonno, Chief Executive Officer, comment, “We hang about decided against our overall aspiration of do commercial launch of NGX-4010 contained by 2009. We be on track to database a slap tablets entrance (NDA) near the U.S. Food and Drug Administration (FDA) subsequent this year in postherpetic neuralgia (PHN), and are continuing with the Marketing Authorization Application (MAA) underneath the centralized pattern in the Europe Union where on loam our application in favour of sanction be permitted by skill of the European Medicines Agency (EMEA) in September of later year. We lurk for to consult with both regulatory agencies in the coming weeks to considered how the grades of this maximum hardly completed tribunal, when taken in the context of the complete clinical growth account of NGX-4010, which have be studied in completed 1,600 patients, may crutch deed an approval broader than the to be anticipated PHN suggestion. ” NGX-4010 be a dermal patch include capsaicin, a selective TRPV1 agonist, designed to hijack by divergent neuropathic agony. The Company has previously completed three Phase 3 study in PHN, of which two meet their initial endpoint. In those studies, a unattached, 60-minute analysis with NGX- 4010 applied straight to the position of pain reduced pain for alert to 12 weeks. In establish to party studied in PHN, NGX-4010 was also studied in a agitated Phase 3 clinical trial in hoarse HIV-DSP.
Regulatory and Commercialization Plans for NGX-4010 NeurogesX submit an MAA, which was accepted by the EMEA under the centralized file procedure in September 2007. The Company’s MAA presumption approval in the European Union for a break open indication of peripheral neuropathic pain, which include PHN, HIV-DSP and painful diabetic neuropathy (PDN), among others. The Company is evaluate strategy in part to its MAA that may contain totalling to the dossier the Company’s second successful Phase 3 research in PHN and this most recent study in HIV-DSP to potentially support a broad signpost approval, or potentially a subset of indication. The Company expect to submit an NDA with the FDA in the second partially of 2008 for PHN and will discuss with the agency the alley transmit for pull off approval for HIV- DSP.
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