Selecting Appropriate Dose Regimens for AM-101 in the Intratympanic Treatment of Acute Inner Ear Tinnitus

Author:

Staecker Hinrich,Maxwell Kenneth S.,Morris John R.,van de Heyning Paul,Morawski Krzysztof,Reintjes Frank,Meyer Thomas

Abstract

Inhibition of cochlear N-methyl-D-aspartate (NMDA) receptors with AM-101, a small molecule antagonist delivered by intratympanic injection, represents a novel approach to treat acute tinnitus triggered by glutamate excitotoxicity. An earlier double-blind, randomized, placebo-controlled phase II clinical trial (TACTT0) had demonstrated a significant and dose-dependent improvement in tinnitus triggered by acute acoustic trauma or otitis media from baseline to day 90. A second phase II trial (TACTT1) now sought to evaluate the most appropriate dose regimen for this treatment. Outcomes from the TACTT1 trial showed no significant difference in tinnitus improvement between a single-dose treatment and a dose regimen comprising three doses over 2 weeks. Taken together, three injections over 3 consecutive days showed the best results in the two phase II trials, suggesting that repeated and concentrated inhibition of cochlear NMDA receptors provides best treatment effects, while keeping the procedural impact on patients short.

Publisher

S. Karger AG

Subject

Speech and Hearing,Sensory Systems,Otorhinolaryngology,Physiology

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1. Unveiling the Role of Oxidative Stress in Cochlear Hair Cell Death: Prospective Phytochemical Therapeutics against Sensorineural Hearing Loss;International Journal of Molecular Sciences;2024-04-12

2. Intratympanic Gels for Inner Ear Disorders: A Scoping Review of Clinical Trials;Otolaryngology–Head and Neck Surgery;2024-02-03

3. Transtympanic medicine instillation- my experience;IP Journal of Otorhinolaryngology and Allied Science;2023-10-15

4. Current Clinical Trials for Tinnitus;Otolaryngologic Clinics of North America;2020-08

5. Why Is There No Cure for Tinnitus?;Frontiers in Neuroscience;2019-08-06

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