Esketamine: Phase IIb data

A double-blind, European Phase IIb trial in 248 patients aged 18-65 with persistent acute inner ear tinnitus showed that 3 intratympanic injections of 0.27 or 0.81 mg/mL AM-101 over 3 consecutive days each missed the primary endpoint of improving minimum masking level from baseline to day 90 vs. placebo (7.9 dB for both doses vs. 8.2 dB for placebo, p=0.9919). Auris said that AM-101 did demonstrate a dose-dependent and persistent improvement in several patient-reported outcomes vs. placebo. In patients with unilateral tinnitus following acute acoustic trauma or otitis media, 0.81 mg/mL AM-101 significantly improved tinnitus loudness, annoyance, tinnitus-related sleep difficulties and overall tinnitus impact as measured by the THI-12 questionnaire from baseline to day 90 vs. placebo (p<0.02 for all). Specifically, the mean improvement in tinnitus loudness at day 90 was 28% in the low-dose AM-101 arm and 48% in the high-dose AM-101 arm vs. 9% for placebo. Additionally, 44% of patients in the low-dose AM-101 arm and 64% of patients in the high-dose AM-101 arm rated their tinnitus severity as "much improved" or "very much improved" at day 90 vs. 35% of patients receiving placebo. ...