NeurogesX (NGSX) Confirms FDA Panel Did Not Recommend Approval of Qutenza
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NeurogesX (Nasdaq: NGSX) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to the U.S. FDA did not recommend FDA approval of a new indication for Qutenza® (Capsaicin) 8% patch for the management of neuropathic pain (nerve pain) related to HIV associated peripheral neuropathy (HIV-PN).
While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application (sNDA) remains under evaluation, with Priority Review status granted by the FDA. A decision from the Agency is expected by March 7, 2012, under the Prescription Drug User Fee Act (PDUFA).
The Committee's recommendation followed today's presentations by the Company and the FDA. The Committee reviewed the efficacy and safety data from clinical studies of Qutenza® in the management of pain associated with HIV-PN.
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While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application (sNDA) remains under evaluation, with Priority Review status granted by the FDA. A decision from the Agency is expected by March 7, 2012, under the Prescription Drug User Fee Act (PDUFA).
The Committee's recommendation followed today's presentations by the Company and the FDA. The Committee reviewed the efficacy and safety data from clinical studies of Qutenza® in the management of pain associated with HIV-PN.
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