Auris Medical’s otoprotective drug AM-111 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of acute sensorineural hearing loss (ASNHL), a condition which may occur following various inner ear injuries. ASNHL may be provoked by exposure to excessive noise, viral or bacterial infections in the inner ear, disturbances of the inner ear blood supply, middle and inner ear surgery and a variety of other incidents. If left untreated, ASNHL may result in permanent, irreversible hearing loss. The clinical development with AM-111 was launched in January 2006 with a phase I/II clinical trial evaluating the drug’s safety in patients with ASNHL from acute acoustic trauma.
