Broad Label Indicated for Peripheral Neuropathic Pain in Non-Diabetic Adults
Conference Call Scheduled Friday, March 20 at 9am ET
SAN MATEO, Calif., March 19 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Qutenza(TM) (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 is a high-concentration capsaicin dermal patch designed to provide rapid, localized and sustained relief from peripheral neuropathic pain. The CHMP's positive recommendation will be evaluated by the European Commission, and a decision on marketing authorization is expected in the next 60 to 90 days.
Anthony DiTonno, President and CEO, commented, "The CHMP's positive recommendation for approval of Qutenza in the European Union provides significant validation for both Qutenza and NeurogesX. Since its founding in 2000, NeurogesX has been dedicated to bringing Qutenza to market for patients with neuropathic pain, a patient population that is largely unsatisfied with existing approved therapies. We are excited to be on the doorstep of potential commercialization. In preparation for a potentially positive final decision by the European Commission, we will be focused on finalizing a relationship with a commercial partner in Europe over the next few months."
Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We believe that, if approved, Qutenza may become an important addition to the treatment options currently ava
|SOURCE NeurogesX, Inc.|
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