Auris Medical reaches midpoint for enrollment in Phase 1b AM-201 trial
Auris Medical announced that it has reached the midpoint for enrollment in its Phase 1b proof-of-concept trial of AM-201, the company's investigational drug for the prevention of antipsychotic-induced weight gain and somnolence. The Phase 1b trial with AM-201 is being conducted at one European site. The trial will enroll in total 50 healthy volunteers who will receive either AM-201 or placebo concomitantly with the antipsychotic drug olanzapine over four weeks. The protocol is based on a dose escalation with five different doses of intranasal betahistine. The first two dose cohorts have been completed and the next ten study participants have been enrolled into the third dose cohort. The primary efficacy outcome for the study will be the reduction in weight gain; the secondary outcome will be the reduction in somnolence.