(273) Clinical trial results: A randomized, double-blind, placebo controlled, trial of three-day bupivacaine transdermal patch (ELADUR) in patients with post-herpetic neuralgia

ELADUR, developed by DURECT Corporation using its TRANSDUR transdermal patch technology, is designed for sustained delivery of an aminoamide anesthetic bupivacaine over a course of 3 days from a single application for localized persistent pain control. The Phase 2a study, conducted at 7 US sites, enrolled 56 patients with Post-Herpetic Neuralgia. The trial was aimed at investigating systemic and dermal safety as well as magnitude, duration and characteristics of analgesia from a single application of three ELADUR patches as compared to placebo applied to the area of most severe pain affecting large dermatome(s) in the two-way crossover study design. An interim analysis on 36 subjects demonstrated a positive trend in reduction of average daily pain collected by the Numeric Rating Scale (0-10) and Subject’s Global Impression of Change, a 7-point categorical scale. The 3-day treatment course was well tolerated. There were no adverse systemic reactions to bupivacaine, no contact dermatitis and no erythema reported following application of ELADUR patches. The enrollment of subjects continued to the study completion. Research supported by DURECT Corporation.