AM-201

AM-201 for treatment or prevention of antipsychotic-induced weight gain and drowsiness

Auris Medical is developing AM-201, an intranasal formulation of betahistine, for the treatment or prevention of antipsychotic-induced weight gain and drowsiness / somnolence. Weight gain and associated metabolic problems such as impaired glucose tolerance and new-onset diabetes, hyperlipidemia, and cardiovascular disease and drowsiness are major side effects of drugs for schizophrenia and/or bipolar disorder.

Oral betahistine is approved for the treatment of vertigo and Meniere’s disease in about 115 countries worldwide, but not in the United States.


How AM-201 works

Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. Histamine plays key role in the brain’s regulation of food intake and energy expenditure. Some antipsychotic drugs are potent H1 histamine receptor antagonists. It could be shown that by counteracting the blocking of the H1 histamine receptor, betahistine attenuates histamine mediated weight gain and drowsiness.


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 initiated a second Phase 1 trial of intranasal betahistine in the first quarter of 2018.

AM-125 Fact Sheet