NeurogesX Inc. (NGSX) announced that the Anesthetic and Analgesic Drug Products Advisory Committee or AADPAC to the U.S. Food and Drug Administration did not recommend FDA approval of a new indication for Qutenza or Capsaicin 8% patch for the management of neuropathic pain or nerve pain related to HIV associated peripheral neuropathy or HIV-PN.
NeurogesX said that currently, its supplemental new drug application 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).
Qutenza (capsaicin) 8% patch, containing a prescription strength capsaicin, is approved by the U.S. Food and Drug Administration for the management of neuropathic pain associated with postherpetic neuralgia (PHN). Qutenza is also approved in the European Union and is marketed by Astellas Pharma Europe Ltd., the European affiliate of Tokyo-based Astellas Pharma Inc.
The company said that Clinical studies have shown that a single one-hour Qutenza application can provide three months relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles. In clinical trials, serious adverse reactions included application-associated pain and increase in blood pressure.
by RTT Staff Writer
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