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Safety of Intratympanic Injection of AM-101 in Patients with Acute Inner Ear Tinnitus

2011; Karger Publishers; Volume: 16; Issue: 6 Linguagem: Inglês

10.1159/000322641

1421-9700

Guido Muehlmeier, E. Biesinger, H. Maier,

Respiratory and Cough-Related Research

Effective pharmacological treatments for tinnitus have proven elusive. Emerging evidence suggests that dysregulation of cochlear N-methyl-<i>D</i>-aspartate (NMDA) receptors may underlie aberrant excitation of the auditory nerve, which in turn is perceived as tinnitus. The blocking of these receptors thus represents a promising therapeutic approach. In a recent phase I/II clinical trial, the safety and local tolerance of intratympanic injections of the NMDA receptor antagonist AM-101 was evaluated for the first time in humans. The results from the double-blind, randomized, placebo-controlled study show that intratympanically injected AM-101 was well tolerated by study participants, and provided the first indications of therapeutic efficacy.