| Aesthetic Medicine Today |
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| Chili based Pain Patch for Post-Herpatic Neuralgia Approved by FDA November 18, 2009 — Qutenza, a non-narcotic pain management patch made by Lohmann Therapie-Systems AD was approved today by the FDA. Qutenza is an 8% capsaicin (chili) dermal patch indicated for the management of pain associated with postherpatic neuralgia (PHN). Phase 3 studies submitted to the FDA revealed that each 1 hour treatment session improved PHN symptoms when applied directly to the PHN afflicted skin region. Approximately 1% of patients on the 8% capsaicin patch discontinued the study because of adverse events. Adverse events included erythema, application-site pain, itchiness, blisters, and an unexpected increase in blood pressure of 10 mmHg lasting for over 2 hours after patch removal. Burning of the eyes and other mucous membranes was also reported from the aerosolization of the capsaicin during patch removal. While differing lower concentrations of capsaicin are found in multiple OTC products, capsaicin 8% patch was granted orphan drug status by the FDA in the treatment of PHN opening the door for other pain management treatment applications. |
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