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. This article 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 1/2 trial was recently completed, and now the company is advancing OTO-313 into full Phase 2 development.
Gacyclidine Tinnitus: Clinical Trials OTO-313
The Phase 2 trial is designed to be based on the successful Phase 1/2 trial, and initiation was scheduled for the first quarter of 2021. In July of 2020, Otonomy reported positive top-line results from Phase 1/2 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.
Phase 2 involves a more expanded population of patients with tinnitus in just one ear. In order to make the study more robust, the researchers are disallowing patients with severe hearing loss from being included, and they are also increasing the minimum score of the Tinnitus Functional Index required for entry, meaning more patients are eligible for entry. The researchers are also allowing more individuals to enter based on the timeline of their tinnitus and are extending the observation period to assess the durability of the treatment effect.
OTO-313: A Tinnitus Cure In Development?
So far, the data from the OTO-313 trials have involved a fairly limited sample size. But as the drug gains more traction and undergoes clinical trials, the more the sample size—and thus, the population being studied—will continue to grow.
Of course, these projections are only based on success in the trials. So if data and research emerges saying that the drugs are not successful in an objective double-blind manner, then funding and interest in these trials will diminish. But if the results show promise, then funding and interest will likewise increase.
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 your tinnitus, then these kinds of drugs could potentially offer relief, so they are worth monitoring closely for the time being.
To learn what may help you manage your tinnitus, please download our free 10-page e-book, The Ultimate Guide to Tinnitus Relief. Dr. Thompson also offers online Tinnitus Retraining Therapy with Pure Tinnitus.