Otonomy OTO-313 — Treatment of Tinnitus

No way! That’s good news man.

 

Mine is indeed caused by TMJ. I got a couple of punches on my head for actually no reason at all. On my audiogram there was no visible hearing loss, so that's why I know for sure that it settles in the brain. But there are more than 200 causes of tinnitus.

I hope OTO-313 will also solve tinnitus for people without any hearing loss.

 

Thank you for letting us know @Sentinel. It's great that you're getting better and I hope that this effect sustains. Enjoy your life in (relative) silence!

 

I'm really hoping this can work for long-term tinnitus. I'm 3 months in and the idea that the window of opportunity is going to slowly pass and be gone by the time the drug is commercialized is terribly sad. Gives me a feeling of powerlessness.

 

My guess is if it works for those who have had tinnitus for 3-4 months, it will work for chronic cases too, because I have witnessed many people after 4-5 years just healing spontaneously or by changing diets, so I think it´s bullshit that it´s stuck in the brain.

When someone habituates, the brain should fix itself after a while but it doesn´t, which shows that there is a cause and once that is removed, the tinnitus will go away too.

 

Yes but for those people (and that aren't just a few) who don't have hearing loss but do have a unlivable tinnitus, just a cure for tinnitus would mean the world for them.

For me it would mean that I can regain my life, which I lost on a very stupid way.

Personally I think that if the only problem you have is that you can't go to festivals anymore you don't have a problem at all, I mean after all you could miss festivals, right? For me it means that not only can't I go to festivals anymore, but my life has also become unbearable and I can't do anything anymore. I really have to say that if there was a cure which meant that I would lose my hearing but also lose my tinnitus, I would take it without any kind of hesitation.

Additionally, I guess for people who have hearing loss, only solving the tinnitus will already make a world of difference.

 

As well as that whole issue with somatic tinnitus. If it is just stuck in the brain, then why does the sound significantly change when I move my jaw or pull back on my scalp. Seems like there is some sort of continued input going on.

 

I agree. I can manipulate the volume of my tinnitus by clenching my jaw… and when it starts to rise in volume, for some reason staying hydrated helps a little bit. I think that tinnitus is linked to some kind of nerve damage that can be fixed and theoretically quieten tinnitus.

 

#Absolutely, I could live with some hearing loss as hearing aids will help, but my tinnitus is like yours, it is severely affecting my life.

 

I could have just made the earlier study, but at the time no one on the forum thought much of OTO-313, so I took a pass... shame.

Now... I am outside the window since I am at 20+ months. Like some... I got this through no fault of my own, other than trusting a medical “professional.”

 

@Sentinel

Some desperate people here are dying to hear how’s it going

Still the lowest tinnitus you ever have experienced since you got it half a year ago?

Hope you’re doing well

 

Well, there was only a 50% chance of you actually receiving the drug rather than the placebo, so it's not necessarily a loss (except in terms of the potential to add another datum to the study).

 

Me too. Let us know @Sentinel how it’s going

 

Dear everyone:

I know your intentions are not bad, but please consider that a drug succeeds only if the treatment group beats the placebo group by a large amount.

In other words, everyone joining the trial with "optimism" is NOT a good thing for a clinical trial. Please, please, please stop documenting this stuff. Both FX-322 and OTIVIDEX (failed two Phase 3 trials!) were impacted by placebo belief.

 

Still got that low tinnitus! I'm actually at the clinic right now waiting on my hearing test before I go home. I spoke with the nurse who does all my visits and she told me that out of the 4 people dosed at the clinic so far, me and one other have experienced improvement, which I guess isn't bad as far as the odds go.

Also slightly unrelated note, this clinic is currently enrolling for the OTO-413 trial which I found interesting. I was talking to the nurse about tinnitus and Otonomy and it came up. I don't fit the trial criteria but it's nice to know.

Good to see things progressing.

EDIT:

I just was in the sound proof room they use for testing and all I could hear was faint static.

 

@Sentinel:

You seem like a really sweet and kind person. Your intentions are wonderful and you have a heart of gold. Very kindly, I want to try to explain why I disagree with you chronicling your experiences.

The main primary end point in this trial is TFI. If you look through the TFI test, many of the questions are based on distress/QoL/outlook. I did the math and for someone to become a "responder," (a TFI reduction of at least 13 points), they basically need to improve by 20% in these highly subjective areas.

Let's say a placebo patient "spots" something in this thread from your chronicling. They could easily become a responder. While this isn't your fault, hearing metrics are very primitive so all of the standards fall back on antiquated tests like TFI, which are not that scientific or hearing based.

There's a historical precedence of "placebo performances" hurting trials. In fact, Otonomy's own Meniere's drug, OTIVIDEX, made its way all the way to Phase 3. It ended up failing two trials because of strong placebo performances. Actually, the drug worked for the people who followed the protocol.

I can't emphasize enough how much these companies are up against the wall. The "hope" is just not worth it. Remember all of the "hope" we all had before FX-322 Phase 2? Yeah, it came crashing down. It is far more important for drugs to demonstrate a strong stratification between the placebo and treatment group.

The nurse telling you these things is highly irresponsible. Trust me, hope does not help clinical trials succeed.

With this said, you are a sufferer and I really hope you find relief. You seem like a good dude.

 

Thank you so much for an update. Very happy for you! For many here this brings a little hope back. If they get this to market, it will be a much needed cash flow and keeps the other companies on their toes

Have a great day!

 

Thank you for the update. I'm rooting for you!

 

Thanks for posting Exit. It means the world to me. I am very hopeful for the future.

 

Awsome news! Maybe the other two that didn’t improve were given placebo, who knows.

 

That’s wonderful @Sentinel!

When will you have the results of your hearing test?

 

So the hype builds... again.

Can't get an erection just yet.

I'm so used to tinnitus research failures that it's part of my life now.

Wish them the best of luck though and all the riches in the world if they've cracked at least part of the puzzle.

 

It's just a routine test, my hearing is fine. They only tell me about the results if there is something anomalous.

 

We need another superhero who has had the injection and wants to post about their experience.

 

Overall I think this is positive, we can only hope.

 

I can do a round of OTO-6XX

 

@Sentinel, thank you for your posts. They are encouraging.

Did the trial administrator just ask you how long you have had tinnitus?

 

Thanks for the updates @Sentinel. So glad OTO-313 appears to be working.

Anyone have an approximate release date assuming everything goes smoothly?

Any FDA fast track going on with this?

 

FDA Phase 2 is expected to end August 2022. Phase 3 will likely start months after that and take over a year to complete. Maybe late 2024?

 

Yes, they did. They took anyone into that trial that had it less than a year.