OTIC - Otonomy sinks after Otividex fails in late-stage trial for Ménière's disease

Otonomy (OTIC) has lost ~50.3% in the premarket after the announcement of the clinical trial failure for OTIVIDEX in patients with Ménière’s disease.Based on topline results, the Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, the company said.The primary endpoint was the count of definitive vertigo days in month 3 for OTIVIDEX vs. placebo, assessed using the Negative Binomial model for the intent-to-treat (“ITT”) population (n = 148; p-value = 0.312).However, for the per-protocol (“PP”) population, the analysis has achieved the statistical significance (n = 136; p value = 0.031). The results looked similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).Expressing the disappointment over the results in the primary intent-to-treat population, David A. Weber, CEO of Otonomy, said that the company was “undertaking an assessment to understand the difference observed with the per-protocol analysis.”He

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Otonomy sinks after Otividex fails in late-stage trial for Ménière’s disease