NeurogesX Inc, a biopharmaceutical company focused on developing and commercialising novel pain management therapies, announced that the European Commission (EC) has formally granted marketing authorisation for Qutenza 179 mg cutaneous patch (formerly NGX-4010) for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. Qutenza can only be obtained with a prescription. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union.
The approval of Qutenza follows a positive opinion recommending approval from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on March 19, 2009. Qutenza, a cutaneous (dermal) patch, is designed to locally deliver a high-concentration (8 per cent) of the active substance capsaicin and to provide sustained relief from peripheral neuropathic pain. Following application to the painful areas on the skin, Qutenza is allowed to remain in place for 30 minutes for the feet (e.g., HIV-associated neuropathy) and 60 minutes for other locations (e.g., postherpetic neuralgia). Qutenza is not indicated for adults who have diabetes as there is only limited experience with Qutenza in patients with Painful Diabetic Neuropathy (PDN), and repeated treatments with Qutenza in patients with PDN have not been studied.
NeurogesX anticipates that Qutenza will be marketed in the European Union through a commercial partner.
Anthony DiTonno, president and CEO, commented, "The European approval of Qutenza represents a major milestone for NeurogesX. It marks the culmination of years of development efforts by the NeurogesX team and represents a validation both of our people and of Qutenza. This also signifies our transition to a commercial enterprise. Although we expect to commercialize Qutenza in the EU with a commercial partner, we have been preparing for this day for quite some time. We anticipate completing our discussions with a European commercial partner in the next few months and believe that a launch of Qutenza in the EU could take place early next year."
Dr Jeffrey Tobias, chief medical officer, noted, "NeurogesX is proud to be able to provide this new treatment option for non-diabetic patients with peripherial neuropathic pain. These patients will now have access to a non-systemic treatment delivered directly to the site of pain that can produce up to three months of pain relief following a single 30- or 60-minute application."
In October 2008, the company submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) requesting marketing approval of Qutenza for the management of pain associated with postherpetic neuralgia (PHN). In December 2008, the NDA was accepted by the FDA for review, resulting in a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.
NeurogesX is a biopharmaceutical company focused on developing and commercializing novel pain management therapies.