Otonomy OTO-313 — Treatment of Tinnitus

[Sentinel]

Has your improvement continued or did you revert to baseline?

After the improvement in the highest tone it has remained that way and all since spikes have reverted to new baseline. All good.

 

[Don Tinny]

Can OTO-313 affect the glutamate levels in the whole brain or does it just work in the cochlea?

I know it's locally injected but I talk about systemic absorption.

 

[Hottopic29]

So if OTO-313 can block tinnitus, will that help with neuroplasticity to keep the tinnitus gone?

 

[David S]

How many reports do we have so far about the OTO-313? Just one or two? Must be much more people out there? Do you think candidates are told not to share information on forums?

Does anyone know what is the main difference between AM-101 and OTO-313?

 

[Watasha]

Does anyone know what is the main difference between AM-101 and OTO-313?

This "might" be covered in the Tinnitus Talk Podcast, I cannot remember. I do believe that Otonomy has a novel delivery mechanism though that allows deep penetration in the ear.

 

[star-affinity]

Can OTO-313 affect the glutamate levels in the whole brain or does it just work in the cochlea?

I know it's locally injected but I talk about systemic absorption.

I asked Otonomy and got the following response (shared with permission):

Most of the drug OTO-313-stays in the cochlear epithelium after administration. The amount that goes systemic and into the plasma is tiny, and almost undetectable. So anything that could get to the brain would also be extremely low. There is a slide about where it goes in the corporate presentation, slide #6, on the company website.

 

[Gb3]

How many reports do we have so far about the OTO-313? Just one or two? Must be much more people out there? Do you think candidates are told not to share information on forums?

Does anyone know what is the main difference between AM-101 and OTO-313?

According to the clinical study site, 153 participants were enrolled. As I recall, one person on here said they were selected, and another backed out due to other members making them scared.

 

[doodlz]

I hope it succeeds and that we can all have the shot, but is it one of those shots that you need to go and get every few months or so to keep it working?

 

[Always Hopeful]

I was in the OTO-313 trial. I was in it last year, I apologize for never commenting, I try to avoid tinnitus websites as much as I can. I still do not know if I got placebo or not, but my tinnitus has improved since the injection. I don't know if it was the natural process of healing or not, but the tinnitus has improved. I usually only notice it at night unless I look out for it.

One thing to note is that in order to get the injection, they have to first put a numbing agent in the ear. They then have to suck it out with suction, not sure if the suction is optional or not. The suction noise is pretty loud, might be harder on the hyperacusis sufferers.

 

[David S]

I was in the OTO-313 trial. I was in it last year, I apologize for never commenting, I try to avoid tinnitus websites as much as I can. I still do not know if I got placebo or not, but my tinnitus has improved since the injection. I don't know if it was the natural process of healing or not, but the tinnitus has improved. I usually only notice it at night unless I look out for it.

One thing to note is that in order to get the injection, they have to first put a numbing agent in the ear. They then have to suck it out with suction, not sure if the suction is optional or not. The suction noise is pretty loud, might be harder on the hyperacusis sufferers.

Thanks for coming back and letting us know. What type of tinnitus did you have? Stable tone or something different? Cicadas? Electric buzzing?

 

[Brian Newman]

I was in the OTO-313 trial. I was in it last year, I apologize for never commenting, I try to avoid tinnitus websites as much as I can. I still do not know if I got placebo or not, but my tinnitus has improved since the injection. I don't know if it was the natural process of healing or not, but the tinnitus has improved. I usually only notice it at night unless I look out for it.

One thing to note is that in order to get the injection, they have to first put a numbing agent in the ear. They then have to suck it out with suction, not sure if the suction is optional or not. The suction noise is pretty loud, might be harder on the hyperacusis sufferers.

Did they tell you not to talk about the trial at all? I'm glad your tinnitus got better.

Do you think candidates are told not to share information on forums?

I don't think they are supposed to share. Placebo can affect results.

 

[Wrfortiscue]

I hope it succeeds and that we can all have the shot, but is it one of those shots that you need to go and get every few months or so to keep it working?

I think if the shot worked, most would be happy going for routine injections. At least for now.

 

[Toby1972]

Is it always the case that you won't find out whether you had the placebo or the drug?

 

[dbeats]

Is it always the case that you won't find out whether you had the placebo or the drug?

I'm guessing the patient could find out after the trial results are published?

 

[GoatSheep]

They then have to suck it out with suction, not sure if the suction is optional or not. The suction noise is pretty loud, might be harder on the hyperacusis sufferers.

Great, another issue for hyperacusis/noxacusis sufferers and getting these treatments. Susan Shore's treatment requires sound played directly into the ear, and now this.

 

[DimLeb]

@GoatSheep, yeah... If ENTs had suction devices that didn't make 999 dB noise levels 3 cm away from the cochlea, that'd be great.

 

[Always Hopeful]

Thanks for coming back and letting us know. What type of tinnitus did you have? Stable tone or something different? Cicadas? Electric buzzing?

I have the kind of whooshing type of tinnitus or beeping noise, sometimes I can't really tell the difference.

Did they tell you not to talk about the trial at all? I'm glad your tinnitus got better..

This never came up during the trial. Thank you.

Great, another issue for hyperacusis/noxacusis sufferers and getting these treatments. Susan Shore's treatment requires sound played directly into the ear, and now this.

It was loud, but it was only for a few short moments, maybe one can prepare for it with NAC, Prednisone, benzo etc. I hope they can find a way around this as well.

 

[Gb3]

I think if the shot worked, most would be happy going for routine injections. At least for now.

That is something they plan on testing in the next trial, or a greater dose.

 

[NYCGuy]

I'm guessing the patient could find out after the trial results are published?

Correct.

 

[blamingeverything]

I have the kind of whooshing type of tinnitus or beeping noise, sometimes I can't really tell the difference.

This never came up during the trial. Thank you.

It was loud, but it was only for a few short moments, maybe one can prepare for it with NAC, Prednisone, benzo etc. I hope they can find a way around this as well.

How soon after the onset of your tinnitus did you receive the injection?

 

[Nobody19]

Great, another issue for hyperacusis/noxacusis sufferers and getting these treatments. Susan Shore's treatment requires sound played directly into the ear, and now this.

Exactly my thoughts as well

Unless we're 100% sure that this helps with hyperacusis, I'm not risking my ears getting even more sensitive.

 

[bill 112]

Exactly my thoughts as well

Unless we're 100% sure that this helps with hyperacusis, I'm not risking my ears getting even more sensitive.

Suction increased my tinnitus drastically in late 2013. I had to get impacted wax out and NEVER again would I do it. I had no idea it was dangerous because "surely if the doctors tell you it's safe, it's safe, right?"

If I get this treatment, they're digging it out manually. No way would I let them suction my ears.

 

[Wrfortiscue]

Exactly my thoughts as well

Unless we're 100% sure that this helps with hyperacusis, I'm not risking my ears getting even more sensitive.

If hyperacusis can be cured, oh boy that would be fantastic.

 

[ZFire]

Exactly my thoughts as well

Unless we're 100% sure that this helps with hyperacusis, I'm not risking my ears getting even more sensitive.

If hyperacusis can be cured, oh boy that would be fantastic.

The studies say 40% of people with tinnitus have hyperacusis and 86% of people with hyperacusis have tinnitus. It's possible that both conditions could have the same underlying cause. If that's the case, I'd imagine it would yield positive results for H as well.

The underlying relationship between tinnitus and hyperacusis is still a mystery though... so only one way to find out unfortunately assuming these drugs work on tinnitus of course...

Here's hoping...

 

[Exit]

Suction increased my tinnitus drastically in late 2013. I had to get impacted wax out and NEVER again would I do it. I had no idea it was dangerous because "surely if the doctors tell you it's safe, it's safe, right?"

If I get this treatment, they're digging it out manually. No way would I let them suction my ears.

Can't we just opt for not getting the drops before the shot?

 

[Damocles]

Can't we just opt for not getting the drops before the shot?

It's just a numbing agent, this should 100% be optional.

I once read an autobiography called Yakuza Moon by a Japanese woman named Shoko Tendo.

She was the daughter of a Yakuza boss, who, as a result of her f*cked up family life went on to become a hostess (aka. prostitute) and drug addict.

At some point in the book one of her boyfriends (also a member of the Yakuza) beat her almost to death and she had to be rushed to hospital for emergency surgery.

The reason I'm sharing this, is because it's always stuck with me, how when she arrived at the hospital, she refused to have any anaesthetic. At the point she had almost been killed, she decided she didn't want another drug in her body. Anyway, after some protest the doctor acquiesced.

So if a person can have an entire arm sewn back together without anaesthetic, I think an injection in the ear without a numbing agent should be negotiable.

 

[Gb3]

Can't we just opt for not getting the drops before the shot?

Doubt it.

 

[NYCGuy]

Can't we just opt for not getting the drops before the shot?

The problem is if they try it without the numbing agent, a needle gets inside your ear and you feel extreme pain, you may jump out of your chair or make a sudden move and that may hurt your ears even more.

 

[VeryUnfortunate]

Can't we just opt for not getting the drops before the shot?

This might be a possibility. There are some people out there who can't go numb from local anesthetic. I spent a lot of time looking into this. Check out this article:

The people who can't go numb at the dentist's

It appears that a similar numbing agent is used for the ear:

Antipyrine-Benzocaine Otic

When one of these people who can't go numb at the dentist, what does the dentist do? Imagine having a root canal or abscess and being one of these people. Surely you can't just ignore the problem, right? Even though you can't go numb and will be in a lot of pain, you still have to operate on your teeth, because your health is at risk.

Now imagine being immune to numbing injections and having tinnitus and hyperacusis and having the option of getting an injection in the ear. I believe the same principle can be applied to people with hyperacusis as the people at the dentist. Sure it's going to hurt, but your mental/physical health is at the same risk as the people at the dentist.

Obviously there is more to this than what I'm saying, like legal issues and stuff like that. But maybe a couple of legal forms can be signed beforehand. And there is the possibility of being under general anesthesia for the procedure, although it would be expensive.

Sorry if some of the stuff I said doesn't make sense, it's late and I typed this on my phone.

The problem is if they try it without the numbing agent, a needle gets inside your ear and you feel extreme pain, you may jump out of your chair or make a sudden move and that may hurt your ears even more.

As @Always Hopeful said, perhaps the patient can receive sedatives like a benzo to calm them down? And maybe they can find out a way to hold the patient in place?

 

[Damocles]

As @Always Hopeful said, perhaps the patient can receive sedatives like a benzo to calm them down? And maybe they can find out a way to hold the patient in place?