Otividex (dexamethasone sustained release) fails in Phase III trial to treat Ménière's disease.-Otonomy.
Otonomy, Inc. announced results for its AVERTS-1 Phase III clinical trial of Otividex (dexamethasone sustained release) in patients with Ménière's disease. The AVERTS-1 trial was a 16-week, prospective, randomized, double-blind, placebo-controlled trial that enrolled a total of 165 patients with unilateral Ménière's disease in the United States. The clinical trial missed its primary endpoint which was the count of definitive vertigo days by Poisson Regression analysis (p=0.62). Patients in both the Otividex and placebo groups showed similar reductions in the number and severity of vertigo episodes during the three month observation period. Otidivex patients reported a 58% reduction from baseline in vertigo frequency in Month 3 vs. 55% for placebo patients. The trial also failed to achieve statistical significance (p < 0.05) for any of the key secondary vertigo endpoints at Month 3.
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