NeurogesX, Inc, a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for approval to market its investigational product candidate, NGX-4010, for the management of pain due to postherpetic neuralgia (PHN). NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2009.
NGX-4010, the company's lead product candidate, is a dermal high-concentration capsaicin patch. The NDA submission is supported by two pivotal studies of NGX-4010 in patients with PHN. The results of these clinical trials show a statistically significant reduction in pain from baseline for up to 12 weeks after a single 60-minute application of the dermal patch. In these studies, NGX-4010 could be administered either as a monotherapy or in combination with other systemic neuropathic pain medications. The most common adverse reactions associated with NGX-4010 were redness, pain, and itching at the application site during and shortly after application. The NDA clinical package includes data on over 2300 patients with neuropathic pain.
Anthony DiTonno, president and CEO, commented, "Our top priority is to secure marketing approval of NGX-4010 in both the United States and Europe. With the submission of our NDA and the ongoing review of our Marketing Authorization Application in the European Union, from which we anticipate a decision in the first half of 2009, we look forward with excitement to the potential for approval and subsequent commercial launch of NGX-4010 in both the United States and the European Union."
PHN is a chronic painful condition that develops in approximately 20 per cent of patients following a herpes zoster (shingles) outbreak. An estimated one million people in the United States develop shingles annually. Current treatments for PHN include antidepressants, anticonvulsants, topical agents and opioid analgesics.
NeurogesX is a biopharmaceutical company focused on developing and commercializing novel pain management therapies.