AM-125 for Treatment of Meniere’s disease and vestibular vertigo

Auris Medical is developing AM-125, an intranasal formulation of betahistine, for the treatment of Meniere’s disease and vestibular vertigo. The intranasal delivery of AM-125 is intended to bypass the effects of first-pass metabolism found with oral delivery of betahistine. This is expected to offer significant additional benefits in terms of efficacy and tolerability.

Oral betahistine is approved for use in more than 80 countries worldwide, but not in the United States.

How AM-125 works

Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. The compound has demonstrated increased cochlear, vestibular and cerebral blood flow, vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. In Meniere’s disease, the objective is the treatment or prevention of vertigo attacks. In the case of vertigo, the objective is to restore balance.

Development stage

In a previous Phase 1 trial, intranasal betahistine demonstrated good tolerance and significantly higher plasma concentrations in comparison with oral betahistine.

Auris Medical plans to initiate a second Phase 1 trial of AM-125 in 2017.

AM-125 Fact Sheet