Safety of Intratympanic Injection of AM-101 in Patients with Acute Inner Ear TinnitusMuehlmeier G.a · Biesinger E.b · Maier H.a
aDepartment of ENT, Head and Neck Surgery, German Armed Forces Hospital Ulm, Ulm, and bENT Clinic and Otolaryngology Department of Klinikum Traunstein, Traunstein, Germany Audiol Neurotol 2011;16:388–397 (DOI:10.1159/000322641)
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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