Otonomy OTO-313 — Treatment of Tinnitus

They only took patients with acute tinnitus.

 

Even if it only treats the acute folks, we are one step closer. Sucks for most of us though.

 

I wanted to wait until my time in the trial ended and the trial was closed for recruiting to speak here since I saw a few here were scared off trying it.

The study is triple masked so I may not ever know if I got drug or placebo. I barely made the cutoff last year for 12 months for screening.

My tinnitus was severe for a year, and it went through all kinds of crazy fluctuations from pure tone EEE to white noise, electric noises to cicadas to high pitch hissing like a water heater. Not overexaggerating when I say I will have PTSD the rest of my life from the tinnitus. It was in my left ear and could hear it outside standing besides 6 lanes of traffic and out at the pool with 5 kids splashing and playing, over my radio turned up to 20 while driving wouldn't cover it up. I took off almost 3 months of work on disability, unable to function from the tinnitus, crying daily and had positional left sided vertigo as well. When people would tell me "oh yeah I have that too, from a concert etc." I would look at them like they were crazy and think to myself the fuck you do while I just nodded uh-huh. Just reiterating I was not a case that was mild in any way or form. The extended audiogram I did with a university here measured the tinnitus at 56 dB and it was not maskable at all from 2 different places I tried.

Back to the trial...

They put numbing gel in my ear and I sat there about 15 minutes. It was suctioned out which I didn't like after hearing all the microsuction horror stories here. After that was done I got the shot and it was a little painful but nothing worse than getting cortisone shots in my feet previously years ago which was excruciating. I went home and the 2 nights trying to sleep were not fun because my ear canal itched like crazy and I had a little pain, but the itching was worse. I kept reading the studies on when people saw improvement and was discouraged a bit until about 2 weeks later. I noticed I started sleeping better. I had struggled a year even with meds getting 2-3 hours sleep and waking up. Coincidentally, I did try CBD/THC gummies also, but as I would explain crying to my mom "my brain wouldn't turn off" to allow sleep. The more my sleep started improving, the better the tinnitus got.

I would always meet the researcher in a tiny room, separate from the regular exam rooms. My first visit before the shot I would sit there thinking OMG, this is so loud! I can hardly concentrate answering this questionnaire! Then every time I would visit her again I would notice it wasn't as loud as previously in the room and I wasn't as distressed as the first visit. It was the same with the hearing exams.

I don't know if it was the drug or time that helped me because I won't know if I received it and neither will anyone else that participated, because it is triple blinded. I am a number in a report. I did joke with the doctor and researcher that if I did get drug that perhaps a few more shots might help even more lol. I am also not as young as some of the other members that reported here of their experiences. I am 47 years old. I have no significant hearing loss and I have never had an ear infection, loud noise exposure, ear problem or head injury. My tinnitus started from probably taking too much pain medication and I awoke one day with left sided positional vertigo and then the tinnitus started about 2 weeks later.

I would say I have moderate tinnitus today. I usually rest at around a 5 out of 10 but rarely I will get a day it's 3 out of 10 and it is still in my conscious thought audible about 70% of my day.

I would like to try other things next, like Lenire, Susan Shore's device or anything else coming down the pipeline to get me to the next "mild" step.

Cheers.

 

Thanks @LostinTX for the update. This is the problem with acute cases, it could be just the result of time. But I’m glad to hear you’re doing better.

 

Thanks for that. Did it help with your tinnitus tones?

 

I go back and forth between a ring and a hiss now. Sometimes the hiss will oscillate. I have never had the white noise machine or cicada sounds return (thank God because those were horribly loud and the worst), but that was prior to the shot. The rare low days I get a sound almost like a tinkering bell far away.

 

That’s awesome! Did the bad tones dissipate right after the injection?

I would be happy with any improvement plus it protecting from tinnitus getting worse haha.

 

No, the tones had disappeared prior to the injection, but the overall volume went down. Still not where I want to be yet. Goal is "only hear in silence" etc.

 

Awesome... let’s get there

 

The goal should be not to hear tinnitus at all.

 

Pretty sure that's everyone's goal here. I should have stated my **NEXT** goal. Cheers.

 

I agree hearing loss is tinnitus's best friend. As my hearing got worse, so did my tinnitus.

 

It's wonderful news that there was any improvement at all. Congratulations, hopefully this is a path to success.

 

So this Gacyclidine has been studied in 2010 on 4 patients with unilateral deafness associated with tinnitus. I think they got temporary relief. I guess Otonomy is now making their own version of this with OTO-313. I hope OTO-313's effect lasts longer.

Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series

 

@LostinTX, happy for your good experience with the OTO-313. Would you do the treatment again if you got the chance?

How do they test possible improvement before and after treatment? Only THI and a hearing test? How much would you say that your THI has improved?

The tinnitus you had sounds very much like mine. Could you feel that it was reactive to certain sounds as well? Did you perceive you tinnitus in the ears or head? I assume taking a shower did mask it?

 

I think this compound will be active for weeks close to the oval window. It is administered via a gel that stays behind the eardrum and cochlea for a long time. I hope that make all the difference.

There are so many animal studies indicating this should work to calm down the overexcited neurons. The key is to get the right amount of the antagonist for the right amount of time.

I think the higher amount of OTO-313 (0.64 ml) that they will test later this year will show to have much better effect. It might also be that some people will need multiple treatments with the lower dose.

How likely is it that FDA can fast track this if everything goes well with Phase 2?

 

They did a study a while back where the patients had a catheter in their middle ear that would dispense Gacyclidine but I think it’s a different formulation.

 

Wouldn’t it be the same?

 

I thought that's what this was being tested for? I thought that's what this entire thing was about.

 

They are testing it for different causes that are one-sided. I mentioned that because I had no noise trauma or ear infection as those are most common cases usually. Something happened to my left ear (possibly medication) causing left-sided vertigo and then tinnitus in that ear. I don't know what happened, and neither do doctors. My guess is though something aggravated the nerve or synapse were affected. Gacyclidine in OTO-313 is NMDA receptor antagonist and supposed to calm down the overactivity in the nerve firings from what I understand.

 

I'm sorry, I missed your question. Yes, they tested my THI in the office visits and I had to do a daily digital diary rating loudness and annoyance. I would guess my THI improved about 15 pts but I don't know as they didn't share the data with me directly.

I would 100% do the shot again or even several times a year if it was the effect of me getting relief.

I was reactive in the beginning of tinnitus for about 3 months and had to wear earplugs drying my hair, walking my dogs because they bark a lot getting ready and vacuuming or noisy kids around. I had a few times it felt in my head in the beginning, but it's always been 24/7 my left ear. I feel as time has moved on it is intermittent in my right (good) ear too, but not very noticeable unless my head is on a pillow. I've mostly slept on my right (good ear) side for over a year now.

 

More good news lol, they moved back OTO-313 results till August. So no more June results.

 

Typical.

My main, quality of life affecting tinnitus is over a year old wow, so it has all moved to the brain, right? Time to give hope to Psilocybin once the pills are approved?

As long as it doesn’t make things worse I’m up for anything... I hope OTO-313 will work for over a year cases too. Please. Pretty please.

 

Tell me about it. This will be my 6th year with tinnitus. After so long you get used to waiting. I think it will help everyone. Would do less for longer cases but could still tone it down, and that’s what matters.

 

I wonder if OTO-313 might also help for the other symptoms mentioned in this article:

”...a constellation of symptoms that include not just hearing loss but also ringing in the ears, sound sensitivity, a feeling of aural fullness and even chronic ear pain.”

That ringing in your ears? Don’t assume it will just fade away.

I have all of those symptoms in my left ear.

Plus that piercing feeling that someone has described as ”lasers om the head”. And also sometimes a little oscillation up in pitch for a second.

Sometimes It’s almost as if the tinnitus sound isn’t the most bothersome. The fullness is really irritating – constantly being aware of the ear. I guess it's all of them together that make it even harder to habituate.

 

Hi!

Does anyone know in which European clinics (countries) OTO-313 was tested in Phase 2?

After they release the results of the trial, is there any chance OTO-313 can be accessed through compassionate use?

Thank you!

 

My fullness is gone right now but when there is pain it really makes it so much harder to ignore the tinnitus. I've gotten pretty good at blocking out the tinnitus MOST of the time now and really just stopped caring about it too much but just certain times like trying to sleep when there's pain is tough.

 

Poland for sure, they did test it in my hometown.

 

Wow, I thought they had clinical trials only in the USA. Since I am from north Slovakia, this is fascinating for me. What town was that?