OTO-313 (intratympanic gacyclidine) Phase 2: negative trial

Record details

Authors: Searchfield GD, et al.
Journal / source: European Archives of Oto-Rhino-Laryngology (2023)
Design: Randomized placebo-controlled Phase 2
Sample: 153
Primary endpoint: TFI responder rate (≥13-point reduction at weeks 4 and 8)
Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No

What this research found

FAILED: responders 26% (OTO-313) vs 36% (placebo), p=0.385 — placebo numerically better. Otonomy discontinued the program and subsequently dissolved.

One of the cleanest demonstrations of the ~30–40% placebo response that plagues tinnitus drug trials.

Limitations and conflicts of interest

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Funding / conflicts: Sponsor-run (Otonomy).

Primary sources

Used as evidence for

Intratympanic drug injections

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.