Otonomy OTO-313 — Treatment of Tinnitus

[xyz]

It's my third year here on Tinnitus Talk (I think). When I joined it was mainly to comment on Lenire that wasn't that far away from commercial launch at that point.

The thing I really liked about Neuromod's approach to their trials was their patient recruitment policy; tinnitus >6 months <5 years. It was the 5 year bit that really got me because what I saw there was a company being realistic about attempting to treat patients who have clearly transitioned from the acute stage to chronic. I thought tinnitus research had suddenly gotten really serious.

I was that star-struck by all of this that I was willing to overlook the lack of placebo control (absolutely something that was within their control) and lack of objective tinnitus measurement metrics (to be fair, not really in their control - but they went with it anyway).

Evidently, the end result for Lenire and Neuromod has been extremely bloody strange to say the least. Fast-forward a few years and here were are; one bizarre dead-end after another like you say.

I do wonder whether we as a patient community have to finally pushback a little more formally against this research space and highlight (in a professional, polite yet firm manner) the obvious elephant in the room, which is cutting-edge scientists trying to develop cutting-edge technology by building it upon a foundation of subjective psychological reporting, which quite frankly, now seems so utterly farcical to me I can't quite believe it's happening.

I was racking my brains trying to think of a way to get the message out to a wider audience. One option I thought might work could be a thirty-second animation - kind of like an infommerical to highlight the absurdity of the situation. I mean, imagine trying to quantify something you can't measure???

Personally I'd rather there were a moritorium on tinnitus curative research until at least The Bionics Institute could get their device out to clinical end users and trials and give us some basic common-sense objective feedback to all this fancy science because until that happens it just seems like hubris to me where researchers in search of their next grant hurl sh*t at the wall hoping some of it will stick, which is fine but as you and I know we're talking about punctured eardrums, electroctuted trigeminals and munching on horse tranquiliser. It's about time we stood our fricking ground.

Anyhow man... sorry for taking this opportunity to rant (it's not directed at you - you know that). Hope you're having some good days.

PS - one of my analogies was - you'd never address a squeak on a car by covering the entire vehicle in oil.
PPS - I like your heart analogy better.

There are also medications for other conditions which are not objectively measurable like pain for example. Why do you think tinnitus research should be stopped? Because the risk that trial participants take is too high? I think that's everybody's free decision.

 

[EkkoMusic]

Maybe a silly question, but Otonomy hasn't published their peer reviewed journal on the detailed results yet, right? (Similar to this for phase I?) We just know it failed but don't have the data yet to sift through ourselves?

 

[UKBloke]

Why do you think tinnitus research should be stopped?

What I actually said:

Personally I'd rather there were a moritorium [sic] on tinnitus curative research until at least The Bionics Institute could get their device out to clinical end users and trials and give us some basic common-sense objective feedback

There are also medications for other conditions which are not objectively measurable like pain for example.

This is not relevant though because there is currently a device out there that has objectively measured tinnitus. @DebInAustralia gave extensive feedback about her own experience at The Bionics Institute.

Because the risk that trial participants take is too high?

Absolutely not. I infer zero jurisdiction over any participant in any trial that I comment about here. At the end of the day, your risk profile in life is for you to manage; my risk profile in life is for me to manage (which incidentally is why, regarding the individual's 'free' decision, I argued so vehemently here against mandatory COVID-19 jabs).

I heard an interesting quote recently about truth. I can't remember it verbatim but it was something along the lines of, truth has it's own special frequency, which is why we know it when we encounter it because it resonates with us.

I dunno... but what I would actually say about tinnitus curative research right now (and maybe it's something more to do with common-sense than the truth of it) is that I don't get a good vibe from it. But hey, what would I know?

 

[Sentinel]

Do you think the trial was affected by placebo?

Certainly in some way, although it remains to be seen to what degree.

 

[Nick47]

A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus

Results: Intratympanic administration of OTO-313 and placebo produced reductions in tinnitus with a similar percentage of TFI responders at Weeks 4, 8, 12, and 16. Reductions in daily ratings of tinnitus loudness and annoyance, and PGIC scores were also similar between OTO-313 and placebo groups. No significant differences in mean TFI scores between OTO-313 and placebo were observed for pre-specified strata regarding tinnitus duration (≥ 2 to ≤ 6 months and > 6 to ≤ 12 months) and TFI baseline scores (≥ 32 to ≤ 53 points and ≥ 54 to 100 points), although the results numerically favored OTO-313 in patients in the ≥ 2 to ≤ 6 months strata. These results also demonstrated an unexpectedly high placebo response particularly amongst patients with chronic tinnitus, despite training implemented to mitigate placebo response. OTO-313 was well-tolerated with a similar incidence of adverse events compared to placebo.

 

[Jupiterman]

So it's REALLY official now.

OTO-313 does NOTHING!

 

[Nick47]

it's REALLY official now.

It doesn't tell us much more we didn't already know, does it? Not even a full publication.