NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced plans to pursue a U.S. label expansion for Qutenza® (capsaicin) 8% patch to include patients with painful HIV-associated neuropathy (HIV-AN, also referred to as HIV-distal sensory polyneuropathy (HIV-DSP)).
Following a recent meeting with the U.S. Food and Drug Administration (FDA), NeurogesX plans to submit a supplemental new drug application (sNDA) in the first half of 2011. The submission will utilize data from two completed Phase 3 studies in patients with HIV-AN.
Anthony DiTonno, President and CEO, commented, "As a company, we are focused on addressing unmet medical needs in pain and have made significant progress towards this goal with the U.S. launch of Qutenza. Our decision to submit a supplemental NDA to address the HIV-AN patient population is important as there are currently no FDA approved treatments for HIV-AN. U.S. label expansion to include HIV-AN would reach a new segment of neuropathic pain patients while leveraging our U.S. sales force and their relationships with pain specialists."
Qutenza is currently indicated in the U.S. for the management of neuropathic pain associated with postherpetic neuralgia (PHN), and has been evaluated in two Phase 3 studies in patients with HIV-AN. The FDA has previously granted orphan drug designation for the use of capsaicin to treat painful HIV-AN and fast track designation for Qutenza for the treatment of painful HIV-AN.