Otonomy slumps as Otividex again fails in Phase III Ménière's disease trial

US ear disorders specialist Otonomy (Nasdaq: OTIC) saw its shares crash 44.3% to $3.00 yesterday, and a further 9.3% to $2.72 pre-market today, after it revealed that the Phase III clinical trial of Otividex, an experimental sustained-exposure formulation of dexamethasone, in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for Otividex versus placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model.

This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).

The drug had also failed to hit the main goal of a similar late-stage trial in 2017, prompting the company to suspend development. It then drew up a revised statistical plan for the most recent Phase III.