NeurogesX, Inc., has announced the approval of an orphan drug designation for Qutenza (formerly NGX-4010), a high-concentration capsaicin dermal patch, to manage neuropathic pain in patients with postherpetic neuralgia (PHN). PHN is a chronic condition that develops following a herpes zoster (shingles) outbreak. Current therapies for PHN include antidepressants, anticonvulsant agents, topical anesthetics, and opioid analgesics.
The FDA is reviewing the company’s New Drug Application (NDA) for Qutenza in PHN. If approved, Qutenza would benefit from seven years of market exclusivity for PHN as a result of this orphan designation.
Source: NeurogesX, June 2, 2009