This excerpt taken from the NGSX 8-K filed Sep 27, 2007.
NeurogesX NGX-4010 MAA Filed and Accepted for Review by EMEA for Treatment of Peripheral Neuropathic Pain
San Carlos, Calif., September 27, 2007 NeurogesX, Inc. (NASDAQ: NGSX), a biopharmaceutical company focused on developing novel pain management therapies, today announced that the Marketing Authorization Application (MAA) submitted by NeurogesX for NGX-4010, the Companys lead product candidate for peripheral neuropathic pain, has been accepted for review by the European Medicines Agency (EMEA).
NGX-4010 is a dermal patch that has been studied successfully in three Phase 3 clinical trials in patients suffering from peripheral neuropathic pain conditions. Two Phase 3 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 EMEA will now begin review of NeurogesX 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 (EU) Member States, as well as Iceland, Liechtenstein and Norway.
Dr. Jeffrey Tobias, Chief Medical Officer, commented, We believe that the data included in our MAA filing, which includes data from more than 1,400 patients studied in our clinical trials, demonstrates the benefit of NGX-4010 in treating patients suffering from peripheral neuropathic pain.
Anthony DiTonno, Chief Executive Officer, 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 (NDA) for marketing approval in the United States in 2008.
NeurogesX recently announced that its second Phase 3 trial of NGX-4010 in postherpetic neuralgia (PHN) met its primary and all of its secondary endpoints. In addition to the Companys PHN studies, NeurogesX has also conducted a successful Phase 3 clinical trial of NGX-4010 in painful HIV-DSP. As recently announced, the Companys second, ongoing confirmatory Phase 3 trial for this indication has reached full enrollment and top-line results are expected near the end of the first quarter of 2008. NGX-4010 has been granted orphan status and has received fast track designation from the U.S. Food and Drug Administration (FDA) for HIV-DSP.