Tinnitus Treatment Report

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OTO-313

Otonomy Now Recruiting Participants for Phase 2 Study of OTO-313 in Tinnitus [Update: New Locations Added]

Otonomy’s recently announced OTO-313 clinical trial was posted to ClinicalTrials.gov on April 2 and will enroll an estimated 140 participants.

Here is a link to the official study record (NCT03918109): A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus

OTO-313 Recruiting April 2, 2021Status: Recruiting

April 11 Update: As we predicted, the OTO-313 study has now expanded its study locations and is currently recruiting in seven states: California, Colorado, Florida, Louisiana, North Carolina, South Carolina, and Utah. (We expected all these locations, with the one surprise being South Carolina.)

The new OTO-313 study is currently recruiting in two locations: Florida and North Carolina.

However, we expect to see more recruitment sites added across the United States in the coming weeks.

Here are some likely states the trial will expand to (based on the previous OTO-313 study locations): California, Colorado, Illinois, Kentucky, Louisiana, New Jersey, New York, North Carolina, Texas, Utah, West Virginia.

International expansion?

It is unknown whether this phase of the trial will expand to other countries.

More updates to follow…

Remember to subscribe to the email newsletter for upcoming OTO-313 updates (and news about other experimental tinnitus treatments in development).

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

https://investors.otonomy.com/news-releases/news-release-details/otonomy-initiates-phase-2-clinical-trial-oto-313-tinnitus

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus
March 25, 2021 at 7:30 AM EDT
Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index (TFI) responder analysis for primary efficacy endpoint
Patient enrollment criteria refined to enrich study population
Top-line results expected in mid-2022

Otonomy expects to start Phase 2 trial of OTO-313 in tinnitus in first quarter of 2021

https://investors.otonomy.com/news-releases/news-release-details/otonomy-provides-update-otividexr-and-oto-313-programs

https://www.globenewswire.com/news-release/2020/11/30/2136417/0/en/Otonomy-Provides-Update-on-OTIVIDEX-and-OTO-313-Programs.html

Otonomy expects to start Phase 2 trial of OTO-313 in tinnitus in first quarter of 2021

OTO-313 in Subjects With Subjective Tinnitus [Completed]

https://clinicaltrials.gov/ct2/show/NCT03918109?type=Intr&cond=Tinnitus&phase=012345&lupd_s=04%2F03%2F2019&lupd_d=14

Condition :   Tinnitus, Subjective

Interventions :   Drug: OTO-313;   Drug: Placebo

Sponsor :   Otonomy, Inc.

Recruiting

OTO-313 in Subjects With Subjective Tinnitus

NCT03918109

Wed, 17 Apr 2019 12:00:00 EDT

Otonomy Provides Update on Clinical Trials: Results from Phase 1/2 trial of OTO-313 for tinnitus expected in July 2020

https://www.globenewswire.com/news-release/2020/06/15/2048357/0/en/Otonomy-Provides-Update-on-Clinical-Trials-and-Development-Programs.html

Otonomy Provides Update on Clinical Trials and Development Programs

June 15, 2020 16:05 ET | Source: Otonomy, Inc.

  • Results from Phase 3 trial of OTIVIDEX® in Ménière’s disease expected in first quarter of 2021
  • Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
  • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020

SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and the timeline to results for the company’s three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Ménière’s disease. The company will host a conference call and webcast today at 4:30 p.m. ET to review these updates.

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