NGX-4010 is a dermal patch that has been studied successfully in three Phase III clinical trials in patients suffering from peripheral neuropathic pain conditions. Two Phase III clinical trials for the treatment of pain associated with postherpetic neuralgia (PHN) and one for the treatment of pain associated with painful HIV-distal sensory polyneuropathy (HIV-DSP) demonstrated that a single 30- or 60-minute treatment with NGX-4010 applied directly to the site of pain may provide pain relief for up to 12 weeks.
Completion of the acceptance period (or validation) signifies that the European Medicines Agency (EMEA) will now begin review of NeurogesX’ marketing authorization application (MAA). The review process is being coordinated by the EMEA under the centralized procedure, which, if resulting in approval, provides one marketing authorization for all European Union member states, as well as Iceland, Liechtenstein and Norway.
Anthony DiTonno, CEO, said: “Validation of our MAA signifies a critical step in our worldwide NGX-4010 development strategy and we look forward to productive interactions with the EMEA in order to potentially gain marketing approval for this novel therapy. We also remain focused on securing a partnering relationship in Europe prior to market approval and are currently in active discussions with potential partners for the commercialization of NGX-4010 in Europe. In addition to our European filing, we anticipate filing a new drug application or for marketing approval in the US in 2008.”