OTO-313 failed as a cure for tinnitus. Here’s why:
It was a pharmaceutical drug developed by Otonomy, a San Diego-based biopharmaceutical company.
OTO-313 was a liquid compound administered via needle injection, past the eardrum, near the cochlea.
(The cochlea is known as the ‘hearing organ’ — its corresponding cochlear nerve carries bio-electric signals up to the auditory cortex, which is how the brain processes sound.)
Now, more specifically…
OTO-313 is a compound by the name of gacyclidine.
Otonomy researchers believed gacyclidine could reduce the severity of tinnitus-related symptoms by strengthening the auditory nerve fibers within the cochlea.
So, the drug was promising.
But after going through multiple clinical trials, it failed.
Trial #1 took place during July of 2020.
It included participants with moderate-to-severe unilateral tinnitus (tinnitus in one ear).
The trial produced a positive clinical response via the Tinnitus Functional Index (TFI).
The TFI is what we use to measure progress (or lack thereof) in treatments, such as loudness and annoyance.
The first research trial showed promise, with a positive clinical response to many participants after only a single injection.
Trial #2 continued in August of 2022, which unfortunately ended in failure.
In other words, there was an insufficient percentage of those reporting reduced symptoms vs the placebo.
So, the study was shut down.
Still, I applaud the researchers’ efforts.
And while this wasn’t an outright success…
It did help expand our knowledge as to what is and isn’t working.
Especially as it pertains to studies using a placebo.
So many research studies in tinnitus, including my own, have not utilized a true double-blind study design, which makes it hard to come to a clear yes-no decision on whether a treatment works or not.
That’s why there’s a long history of tinnitus treatment companies slowly fading away, and eventually ending production of their product.
Thank you to the researchers for Otonomy for giving this treatment a shot. And thanks to the scientific method for allowing us to put this one to rest.
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I'm Ben Thompson, AuD, leading tinnitus specialist, YouTuber and Founder of Treble Health.
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Consultant and Professor, Laboratory Medicine and Pathology, Mayo Clinic
6moFor a lifelong disease, I hope the drugs for sickle cell are affordable.