NeurogesX is planning 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)).
Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the US and the European Union.
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.
In Europe, Qutenza is being marketed by Astellas Pharma Europe, the European subsidiary of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
NeurogesX plans to submit a supplemental new drug application (sNDA) in the first half of 2011, which is expected to utilise data from two completed Phase 3 studies in patients with HIV-AN.
NeurogesX president and CEO Anthony DiTonno said that their decision to submit a supplemental NDA to address the HIV-AN patient population is important as there are currently no Food and Drug Administration approved treatments for HIV-AN.
NeurogesX said that 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.