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news.The US Food and Drug Administration (FDA) has approved to review the supplemental new drug application (sNDA) of NeurogesX's Qutenza (capsaicin) 8% patch as a treatment to manage neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN).
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Qutenza (capsaicin) 8% patch is a localised dermal delivery system comprising prescription strength capsaicin.
Qutenza is currently FDA approved as a 60-minute application for the management of neuropathic pain associated with postherpetic neuralgia (PHN), now the company plans to get approval for a 30-minute application for the treatment of neuropathic pain associated with HIV-PN.
Earlier studies showed that a single one-hour Qutenza application can offer three months relief from pain associated with PHN.
NeurogesX president and CEO Anthony DiTonno said the FDA’s filing and priority review of sNDA for Qutenza in HIV-PN is intended to expand pain management franchise.