Safety of intratympanic injection of AM-101 in patients with acute inner ear tinnitus.

Author(s): Muehlmeier G, Biesinger E, Maier H.

Affiliation(s): Department of ENT, Head and Neck Surgery, German Armed Forces Hospital Ulm, Ulm, Germany. gment @ t-online.de

Publication date & source: 2011, Audiol Neurootol. , 16(6):388-97

Effective pharmacological treatments for tinnitus have proven elusive. Emerging evidence suggests that dysregulation of cochlear N-methyl-D-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.