Otonomy gives up on experimental tinnitus drug after disappointing Phase 2 trial

Neurotology-focused biopharma Otonomy (Nasdaq:OTIC) will cease development of OTO-313 after the experimental drug failed to show clinically meaningful benefit in a randomized, placebo-controlled Phase 2 trial.

The company’s lead asset, OTO-313, did not meet either primary or secondary endpoints in the study, which involved 152 patients with persistent, unilateral tinnitus of at least moderate severity.

OTO-313 is a formulation of the selective N-methyl-D-aspartate (NMDA) receptor antagonist gacyclidine.

The San Diego–based company’s share price dropped almost 80% in mid-day trading to $0.31. On March 13, 2015, its stock price hit an all-time high of $39.36.

[Related: Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients]

The primary endpoint was related to an at least 13-point improvement on the Tinnitus Functional Index (TFI) one month and two months following treatment. For context, t…

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