Safety of Intratympanic Injection of AM-101 in Patients with Acute Inner Ear TinnitusMuehlmeier G. · Biesinger E. · Maier H.
aDepartment of ENT, Head and Neck Surgery, German Armed Forces Hospital Ulm, Ulm, and bENT Clinic and Otolaryngology Department of Klinikum Traunstein, Traunstein, Germany
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.
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