Auris Medical announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Keyzilen (AM-101) for the treatment of acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults.
AM-101 is currently being investigated in Phase 3 clinical trials in adult patients with acute inner ear tinnitus. The company initiated two pivotal studies, one in North America (Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2, or TACTT2) and one in Europe (TACTT3), with results expected in August 2016 and in the fourth quarter of 2016, respectively.
Currently, there is no clinically proven pharmacological treatment available for acute peripheral tinnitus. Keyzilen has the potential to be the first drug to gain approval for this indication.
Keyzilen (AM-101) contains the NMDA receptor antagonist, esketamine hydrochloride, formulated in a biocompatible and fully biodegradable gel.
For more information visit Aurismedical.com.