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Qutenza: Approval of a “DESI-inspired” Drug

This week, NeurogesX, Inc. announced the FDA 505(b)(2) approval of Qutenza(TM), its 8% capsaicin patch, for management of post-herpetic neuralgia (PHN) – the nerve pain that can follow an attack of shingles. While not strictly speaking a DESI product, Qutenza can be considered “DESI-inspired,” because it is a first Rx approval for an active ingredient that has long been marketed in OTC products. Capsaicin occurs naturally in chili peppers, although Qutenza contains a synthetic equivalent. The kind of product that NeurogesX chose to development is instructive. According to their press release, this product has a higher strength of capsaicin than any of the OTC products. Their product  indication, PHN, must be diagnosed and treated by a health care professional (in fact, the Qutenza patches must be applied by a health care professional and side effects must then be monitored for at least an hour). Both of these factors make Qutenza an Rx product. And there has been an unmet medical need for PHN patients because existing treatments often fail to treat the pain or cause unacceptable side effects, like drowsiness. About 10 — 15 % of shingles patients develop PHN, and shingles is most common in patients over age 50, a growing segment of the US population. So there is an important market for the product. NeurogesX is already working on a follow-on product: a topically applied liquid capsaicin formulation for neuropathic pain.