OTO-313 is a new pharmaceutical research drug aimed at finding a cure for tinnitus. The research group Otonomy created OTO-313 to help find a cure for tinnitus sufferers. In this video, I share my analysis and opinion.
There’s a group of researchers working on a drug called OTO-313, which is aimed at curing tinnitus. In this article, I’m going to give an update on this drug’s clinical trials through the group Otonomy, and what these researchers are finding in terms of the drug’s effectiveness at treating tinnitus. Keep reading until the end, where I’ll give my own two cents about OTO-313.
Now let’s get into what the company has to say about how the drug is working. If you go to Otonomy’s website and look at the different programs and compounds they have, you can scroll down and see OTO-313. This drug is designed for tinnitus, and the active compound is gacyclidine. According to the website, “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 they’re advancing OTO-313 into full Phase 2 development.
Gacyclidine Tinnitus: Clinical Trials OTO-313
Otonomy, the creator of OTO-313, is a company from San Diego, California. The Phase 2 trial is designed to be based on the successful Phase 1/2 trial and initiation is expected in the first quarter of 2021. In July of last year, 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 (that means an injection through the eardrum) of OTO-313 using the Tinnitus Functional Index, which is a questionnaire that was correlated with tinnitus loudness, annoyance, and patient global impression of change measures.
The second phase will have a more expanded population of individuals with tinnitus in one ear. In order to make the study more rich with data, they will disallow severe hearing loss from being included, and they will increase the minimum score of the Tinnitus Functional Index required for entry. So that means that more of you could potentially be involved in this study. For the second phase of research, they will also allow more individuals to enter based on the timeline of their tinnitus, and will extend the observation period to assess the durability of the treatment effect.
OTO-313: A Tinnitus Cure In Development?
So far, the data from OTO-313 has a fairly limited sample size. But the more that this drug gains traction and undergoes clinical trials, the more you’ll see the sample size, or the population that’s being studied, continue to grow over time.
Of course, these projections are only based on success in the trials. So if the data and research comes out that the drugs are not successful in an objective double-blind manner, then we’re going to see the funding and interest for these projects start to go down. But if the results show promise, then we’ll see the funding and interest level go up.
As I said, I’ll be monitoring Otonomy and OTO-313, and will continue to analyze the data that comes out to see if this drug can be a potential cure for tinnitus.
Now my thoughts about OTO-313, and how this could help someone with tinnitus. These kinds of drug solutions are something that I’m going to be monitoring closely. It’s a brand new type of tinnitus treatment. Here we have this biomedical research looking into different drug solutions that are being put into the ear, into the cochlea, and how they could change the physiology of the inner ear, the mechanics and the structure of any damaged hair cells or other damaged parts of the hearing system. And if that is the leading cause of your tinnitus, then these kinds of drugs could potentially help you. So you can guarantee I’ll be monitoring it closely.