inner ear disorders
AM-125 for the treatment of vertigo is expected to complete its Phase 2 TRAVERS trial in Q4 2021 and to move into Phase 3 in 2022. Keyzilen® (AM-101) for the treatment of acute inner ear tinnitus and Sonsuvi® (AM-111) for the treatment of acute inner ear hearing loss have both been evaluated in Phase 3 trials, but will require further clinical testing.
AM-125 Phase 1 trial (1)
Dose escalation in healthy volunteers, single dose, placebo controlled (n=40)
AM-125 Phase 1 trial (2)
Dose escalation in healthy volunteers, single dose and 3 doses per day for 3 days, placebo controlled (n=72)
AM-125 Phase 2 trial (TRAVERS)
Treatment of patients suffering from acute vertigo following neurosurgery with 3 doses per day for 4 weeks, followed by 2 weeks of treatment-free period, placebo controlled (n=118)
Intranasal delivery of betahistine results in 5 to 29 times higher plasma exposure compared to standard oral administration.
Accelerated and improved balance function
Dose dependent improvement in balance for neurosurgery patients suffering from acute vertigo