High-Concentration Capsaicin Patch Granted Orphan Drug Designation for PHN

Yael Waknine

June 09, 2009

June 9, 2009 — The FDA this month approved orphan drug designation for a high-concentration capsaicin dermal patch (Qutenza [formerly NGX-4010], NeurogesX, Inc) for the treatment of pain associated with postherpetic neuralgia (PHN).

According to information on the manufacturer's Web site, clinical data suggest that a single topical 30- or 60-minute application of the capsaicin dermal patch may provide up to 3 months of localized pain relief with minimal adverse effects.

The approval was based in part on data from two 12-week phase 3 clinical trials (n = 818) in which patients received either a single 1-hour patch application of the study drug or a low-concentration capsaicin control patch; all patches were applied to the painful area of skin, with maximal surface area covering 1000 cm2.

Results from both studies showed that the high-concentration capsaicin patch yielded significantly greater improvements in pain intensity from baseline compared with the control patch (P = .001 and .01, respectively), as assessed using an 11-point numeric pain rating scale. The most commonly reported adverse events were erythema, pain, and pruritis at the application site during and shortly after patch use.

"The FDA's orphan designation underscores the unmet need of patients suffering from PHN," said Anthony DiTonno, president and chief executive officer of the manufacturer in a company news release.

The FDA is currently reviewing a new drug application for the product and has assigned a Prescription Drug User Fee Act date of August 16, 2009. Other potential applications currently under investigation include treatment of pain associated with HIV-distal sensory polyneuropathy and of pain associated with diabetic neuropathy.

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