NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced it submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking to expand the label for Qutenza (capsaicin) 8% patch to include an indication for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN), also known as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP).
The sNDA seeks approval for a 30-minute application of Qutenza for the treatment of neuropathic pain associated with HIV-PN. As part of the application, NeurogesX is also requesting a Priority Review designation. FDA Priority Review status is given to drug candidates that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from ten months to six months. Qutenza is approved by the FDA as a 60-minute application for the management of neuropathic pain associated with postherpetic neuralgia (PHN), as well as by the European Commission for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain in all 27 countries of the European Union.
"This is an important step forward as we pursue our strategy to obtain broader market access for Qutenza through the expansion of approved indications," said Anthony DiTonno, president and CEO of NeurogesX. "An approval for this indication would be particularly meaningful as the treatment of HIV-PN represents a significant unmet medical need in the HIV community. Currently, no FDA approved drugs are available to treat this complication."
DiTonno continued, "Additionally, as Qutenza is a topical treatment with minimal systemic absorption, it is expected to have minimal risk of drug-drug interactions, a feature that is particularly important in this patient population."
HIV-PN is the most common neurological complication of HIV infection. Many patients with HIV are afflicted with symptoms ranging from mild tingling to severe and excruciating pain. HIV-PN 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.
Qutenza (capsaicin) 8% patch, a localized dermal delivery system containing a prescription strength capsaicin, is approved by the US Food and Drug Administration (FDA) for the management of neuropathic pain associated with postherpetic neuralgia (PHN).
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. The most common treatment-emergent adverse reactions (greater than or equal to 5 per cent of Qutenza patients and greater than control) were application-site erythema, application-site pain, application-site pruritus, and application-site papules.
Qutenza is also approved in the European Union and is marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc.