NGX-4010 is NeurogesX’s novel high-concentration trans-capsaicin dermal patch. In the trial, patients reported statistically significant pain reduction over a 12-week period following a single application of NGX-4010, the study’s pre-specified primary endpoint.
“This is a potential breakthrough for patients suffering from painful HIV-associated sensory neuropathy, a frequent yet difficult to manage neurological complication of HIV infection for which there are currently no approved therapies in the US,” said Dr David Simpson, professor of neurology at Mount Sinai School of Medicine in New York and lead academic investigator in the NeurogesX study.
NeurogesX plans to initiate a second pivotal phase III trial with NGX-4010 for HIV-associated neuropathy (HIV-AN) later this year. The company has been granted fast track status as well as orphan drug designation for NGX-4010 in this indication by the FDA.
“We now anticipate our development plan to include filing a new drug application (NDA) with data from our HIV-AN program as well as our postherpetic neuralgia program in mid-2007,” said Anthony DiTonno, NeurogesX president and CEO. “There is a very large unmet medical need in the treatment of neuropathic pain and this is an important step toward a non-centrally acting option for physicians and patients.”