Approved for peripheral neuropathic pain in non-diabetic adults
SAN MATEO, Calif., May 21 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the European Commission has formally granted marketing authorization of Qutenza(TM) 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%) 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 developm
|SOURCE NeurogesX, Inc.|
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