NeurogesX, Inc, a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced plans to pursue a US 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 US 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 US 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. US label expansion to include HIV-AN would reach a new segment of neuropathic pain patients while leveraging our US sales force and their relationships with pain specialists."
Qutenza is currently indicated in the US 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.
HIV-AN is thought to be caused by multiple factors related to HIV infection including injury of sensory neurons by HIV virus proteins; the immune system's fight against HIV; and some antiretroviral drugs. HIV-AN is the most common neurological complication of HIV infection, and many of these patients are afflicted with symptoms ranging from mild tingling to severe and excruciating pain.
NeurogesX is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies.