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. 

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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.

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