Development of Ethenzamide Ointment as a Pain Relief for Postherpetic Neuralgia

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We previously reported on the development and clinical efficacy of 2 % aspirin ointment (AO) for the topical pain relief of postherpetic neuralgia (PHN). Although 2 %AO has been used clinically in our hospital with high efficacy, the stability of aspirin in the ointment and the acceptability of the ointment to patients were inadequate. Therefore, to improve these points, we changed the active ingredient to ethenzamide and also adopted a wax-based ointment. Three different concentrations (1 %, 2 % and 5 %) of ethenzamide ointment (EO) were then prepared using transdermal absorption enhancers. The antinociceptive effect was tested by the Randall Selitto method in a rat model of hyperalgesia with the ointment applied topically. Both 2 %EO and 5 %EO were found to be as effective as 2 %AO in a rat model of hyperalgesia, and 5 %EO was chosen for further study because it tended to have a longer duration of efficacy in a preliminary clinical study. A high stability of ethenzamide at room temperature for more than 56days was confirmed using high performance liquid chromatography while the stability of aspirin in the ointment was not good enough. The clinical efficacy was tested in 4 outpatients with PHN by dispensing either 2 %AO or 5 %EO weekly in a single-blind crossover study. 5 %EO was thus found to have a quick effect on pain relief and the efficacy was similar to that of 2 %AO. The acceptability of 5 %EO to patients was also better than that of 2 %AO in terms of stickiness. After the trial, the patients were treated with 5 %EO continuously for up to 8 months. This is the first demonstration of the efficacy of ethenzamide as a pain relief medication for patients with postherpetic neuralgia, and 5 %EO is thus considered to be a clinically useful analgesic for postherpetic neuralgia.
日本医療薬学会の論文
2002-08-10

Development of Ethenzamide Ointment as a Pain Relief for Postherpetic Neuralgia

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