There’s a group of researchers from the company Otonomy (based in San Diego, California) working on a pharmaceutical drug called OTO-313, which is aimed at curing tinnitus. We will discuss the drug’s clinical trials as well as the drug’s effectiveness at treating tinnitus.
Otonomy’s website describes OTO-313 as a drug designed to treat tinnitus, mentioning that “OTO-313 is a sustained-exposure formulation of gacyclidine, a potent and selective NMDA receptor antagonist, in development for the treatment of tinnitus.” A successful phase 1 trial was recently completed, and now the company is advancing OTO-313 into full phase 2 development.
It’s important to remember that while this drug is still undergoing research and development, there are effective tinnitus management methods out there that can help you reduce the impact of your tinnitus. Treble Health offers a tinnitus treatment program for those who are dealing with bothersome tinnitus – take our short quiz to find out if you’re a candidate.
OTO-313 Initial Clinical Trials
In July 2020, Otonomy reported positive top-line results from phase 1 of OTO-313 in patients with unilateral tinnitus (tinnitus in just one ear) of at least moderate severity. The trial demonstrated a positive clinical response for a single intratympanic injection of OTO-313 (that is, an injection through the eardrum) using the Tinnitus Functional Index, which is a questionnaire that correlates with tinnitus loudness, annoyance, and patient global impression of change measures.
2022 Update: OTO-313 Phase 2 Trials
The results of the OTO-313 phase 2 clinical trial were announced on August 1st, 2022 and unfortunately they were disappointing. Participants experienced no tinnitus improvement, and the research of OTO-313 as a tinnitus treatment is being discontinued.
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"Treble Health helped me reduce my tinnitus by about 80%, and now I can live my life again!"
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Here are the key points from the recent press release by Otonomy:
- OTO-313 demonstrated no clinically meaningful improvement versus placebo
- Company to discontinue development of OTO-313
While this news is unfortunate, it’s not a complete loss for the tinnitus community. Any time a biotech company invests millions of dollars into tinnitus research, we gain momentum and interest from talented scientists who are inspired to keep trying to cure tinnitus (and who can rule out another method that doesn’t work).
If you were thinking that OTO-313 might be a tinnitus cure, don’t lose hope. While a true cure has not been discovered, there are lots of things we can do to reduce tinnitus. The audiology team at Treble Health can help. We can customize a treatment plan for you, and track your progress over time. We can support you and guide you down the right path. Full habituation is possible. Furthermore, we still have effective tools to help people successfully manage their tinnitus now. Find out if you are a candidate for our tinnitus treatment program that utilizes current evidence-based tinnitus treatments.
How Would OTO-313 Work?
When we first posted about OTO-313, many wondered why the initial trials were only focused on unilateral tinnitus. These folks will be happy to find out that in addition to the ongoing phase 2 trial, Otonomy is currently evaluating the safety for higher dosing of OTO-313, as well as dosing in both ears (bilateral dosing).
As Otonomy’s original theory suggests, OTO-313 hopes to strengthen the auditory nerve fibers in the cochlea (the hearing organ), meaning that different subtypes of tinnitus may not qualify or may not experience noticeable improvement. If phase 2 is successful, Otonomy will then have to meet with the FDA to design the next clinical study, which would then begin in 2023.
OTO-313: A Tinnitus Cure In Development?
OTO-313 and similar drugs represent a brand new type of tinnitus treatment, where different drug solutions are put into the cochlea with the ultimate goal of changing the physiology of the inner ear and altering the mechanics and structure of any damaged parts in the hearing system. If it turns out that this is the leading cause of tinnitus, then these kinds of drugs could potentially offer relief, so they may be worth further development in the future. That said, tinnitus patients should still focus their present efforts on sound therapy and one-on-one counseling with a trained audiologist, as this still represents the best path towards tinnitus habituation. Take our short quiz to see you are a candidate for treatment with Treble Health.
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