Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.NeurogesX, a biopharmaceutical company, has submitted a new drug application to the FDA for approval to market its investigational product candidate, NGX-4010, for the management of pain due to postherpetic neuralgia.
Subscribe to our email newsletter
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 date in the second half of 2009.
NGX-4010, the company’s lead product candidate, is a dermal high-concentration capsaicin patch. The new drug application (NDA) submission is supported by two pivotal studies of NGX-4010 in patients with postherpetic neuralgia.
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. The NDA clinical package includes data on over 2,300 patients with neuropathic pain.
Anthony DiTonno, president and CEO of NeurogesX, said: “Our top priority is to secure marketing approval of NGX-4010 in both the US and Europe. With the submission of our NDA and the ongoing review of our marketing authorization application in the EU, 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 US and the EU.”