Otonomy OTO-313 — Treatment of Tinnitus

[ChrisBoyMonkey]

Being denied for having tinnitus in both ears makes zero sense.

What kind of drug are they trying to develop?

Tinnitus is a matter of the brain and inner ear. Almost all tinnitus patients have it in both ears and in the head. What a shitty drug.

@Rb86 I actually got a better answer when I asked why.

They said it's for safety, since it is only in a phase 1 part 2, it's just in case the drug is not safe they don't want it messing up both ears.

I was mostly happy with that answer, but I'm gonna ask again why can't they just do one ear for those with it on both sides. I imagine it's because it would mess with the TFI, since that is their main measure.

 

[ChrisBoyMonkey]

I don't think I'll be able to say much more, but I'm moving forward with this trial. I'll be going back to my local center to get my my shot soon. 50/50 chance of getting the drug or placebo.

They said no one had gotten worse from OTO-311, and some people had actually gotten better. They didn't know exactly how many, how much it helped or for how long, or maybe they couldn't say it, but there were some positive results.

 

[FGG]

I don't think I'll be able to say much more, but I'm moving forward with this. I'll be going back in my local center to get my my shot soon. 50/50 chance of getting the real thing or placebo.

They said no one had gotten worse from OTO-311, and some people had actually gotten better. They didn't know exactly how much it helped or for how long (or maybe couldn't say it).

Good luck. Wishing you get the drug and healing happens for you!

 

[ChrisBoyMonkey]

Good luck. Wishing you get the drug and healing happens for you!

Thank you so much!

I'm mentally prepared if I only get placebo, but I'm really wishing for it too!

 

[Daniel Lion]

Thank you so much!

I'm mentally prepared if I only get placebo, but I'm really wishing for it too!

Echoing FGG... Good luck and proud of you. You are brave and I am wishing you awesome success and quiet days.

Most sincerely,
Daniel

 

[AfroSnowman]

Thank you so much!

I'm mentally prepared if I only get placebo, but I'm really wishing for it too!

Awesome and exciting. Do you know when you will go in for the shot?

 

[JayK]

Thank you so much!

I'm mentally prepared if I only get placebo, but I'm really wishing for it too!

Congrats! There is one center recruiting currently just 20 minutes from me in NY. I've had Tinnitus for about 10+ years from concerts etc. Just wondering, why did they ultimately agree to recruit you? I have T in both ears as well and I'm wondering if I would be eligible.

 

[acute]

I don't think I'll be able to say much more, but I'm moving forward with this trial. I'll be going back to my local center to get my my shot soon. 50/50 chance of getting the drug or placebo.

They said no one had gotten worse from OTO-311, and some people had actually gotten better. They didn't know exactly how many, how much it helped or for how long, or maybe they couldn't say it, but there were some positive results.

Do you have tinnitus in just one ear?

 

[Juan]

In my opinion, drugs are not going to fix tinnitus. Every year there are a bunch of new supplements and some "meds" and none of them work.

 

[Rb86]

Otonomy emailed me back, responding to my question as to why only unilateral cases were allowed and bilateral cases were dismissed. I was given a phone number and case number to tell them when I called.

So I call. Give my name and case number. "Ok one moment while I look up your case". Hold for a couple minutes. "Ok sir they gave me a response to read to you. It says that they designed the case study so that they can use that information for future case studies, and are currently taking only unilateral patients."

Yes, I know that. We all know this. That doesn't answer the question. Why can't you take on a bilateral tinnitus patient?

"I can't answer that sir."

Then why the fuck did you ask me to call you?

Some real geniuses running the show over at Otonomy. Sorry but all these dumbasses want to play coy and not answer anything, and use our body as guinea pigs for them to get rich. Get real. I'm just tired of dumb shit. Answer a question for somebody.

 

[ChrisBoyMonkey]

Do you have tinnitus in just one ear?

Pretty much it's just in my right. I think I hear it in the left / in my head in quiet places only but other than that my right ear is ringing almost everywhere I go.

Since mine was king of going away, I was pretty much just left with head noise by early July, they agreed that mid july is when this new ringing started.

 

[jay777]

Aww shucks, I'm sorry to hear that. I really feel like this acute and chronic stuff makes not much sense. If the mechanisms are the same, it shouldn't make much of a difference.

It will to THI score.

 

[ChrisBoyMonkey]

It will to THI score.

You probably missed it but that's what I wrote as being the thing too.

It makes sense that if for safety they are only doing one ear, THI would be messed up if the drug works but THI wouldn't change much because the person still has it in the other ear.

 

[FGG]

What kind of research and future treatment are meant for people without hearing loss?

If you have tinnitus, and it's not secondary to a brain injury or TMJ, you have hearing loss even if it's not noticeable to you. This goes into more detail:

https://hearinglosshelp.com/blog/hidden-hearing-loss/

Edit: I realize this was written by Neil Bauman who rightly gets a lit of criticism but he summarized some of Charles Liberman's ideas on this nicely here.

 

[Dosman]

I attempted to participate in this trial but I was told I am not a candidate after answering some questions. They wouldn't tell me what exactly disqualified me, as would be expected. I'm disappointed, but not too disappointed.

 

[FGG]

So... I'm at a vet CE seminar right now and the topic is analgesia and the speaker said something potentially relevant to this--at least in animals.

He said NMDA/AMPA receptors are not activated (much) in acute pain unless it's severe but are greatly activated in chronic/maladaptive pain.

So might this drug work better with severe *or* chronic tinnitus when more of these receptors are activated. If that's the case, this may work better for chronic mechanism unless the pathway activation is so disparate from tinnitus that this is irrelevant.

Especially since I also learned that, like other gating receptors there are a lot of subtypes.

Thoughts?

 

[JohnAdams]

So... I'm at a vet CE seminar right now and the topic is analgesia and the speaker said something potentially relevant to this--at least in animals.

He said NMDA/AMPA receptors are not activated (much) in acute pain unless it's severe but are greatly activated in chronic/maladaptive pain.

So might this drug work better with severe *or* chronic tinnitus when more of these receptors are activated. If that's the case, this may work better for chronic mechanism unless the pathway activation is so disparate from tinnitus that this is irrelevant.

Especially since I also learned that, like other gating receptors there are a lot of subtypes.

Thoughts?

Seems like something is dysregulated. Surely another piece of the puzzle.

 

[GoatSheep]

I was just contacted by WVU in Morgantown about participating in the trial. So far nothing has disqualified me.

I'm sorry but @JohnAdams did you say this is just a single dose if not given the placebo and the effect would wear off?

Any other info would be appreciated anyone. I'm sorry I'm struggling right now to concentrate and research.

 

[GoatSheep]

I don't think I'll be able to say much more, but I'm moving forward with this trial. I'll be going back to my local center to get my my shot soon. 50/50 chance of getting the drug or placebo.

They said no one had gotten worse from OTO-311, and some people had actually gotten better. They didn't know exactly how many, how much it helped or for how long, or maybe they couldn't say it, but there were some positive results.

So you signed an NDA? I may be doing it at WVU. Nothing denied me so far. Initial appointment isn't for a month though.

 

[ChrisBoyMonkey]

So you signed an NDA? I may be doing it at WVU. Nothing denied me so far. Initial appointment isn't for a month though.

Alright, looks like we're in this together!

From the questions I asked, it doesn't really seem like there were any bad side effects from the first trial and some experienced benefit.

Did you also ask them questions like that? I'm hoping their answers would be consistent here lol

 

[GoatSheep]

Alright, looks like we're in this together!

From the questions I asked, it doesn't really seem like there were any bad side effects from the first trial and some experienced benefit.

Did you also ask them questions like that? I'm hoping their answers would be consistent here lol

To be honest I just had osteoma surgery to try and get rid of my tinnitus. I'm pretty bad off at the moment. So I didn't ask a lot of questions. I'll ask more though at the appointment.

My tinnitus is also worse than before surgery. I'm hoping that is just during the healing process, but I'm skeptical. So much for thinking I was lucky and had a shot at getting rid of my tinnitus.

 

[ChrisBoyMonkey]

To be honest I just had osteoma surgery to try and get rid of my tinnitus. I'm pretty bad off at the moment. So I didn't ask a lot of questions. I'll ask more though at the appointment.

My tinnitus is also worse than before surgery. I'm hoping that is just during the healing process, but I'm skeptical. So much for thinking I was lucky and had a shot at getting rid of my tinnitus.

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I'm sorry to hear that, hopefully this drug can help you find some relief. You can always send them an email or ask next time you go, the last thing we want is even worse tinnitus. Based on what I've researched and asked, it seems we're more likely to benefit if we get the real thing, possibly only temporarily though.

 

[Chriscom]

To be honest I just had osteoma surgery to try and get rid of my tinnitus. I'm pretty bad off at the moment. So I didn't ask a lot of questions. I'll ask more though at the appointment.

My tinnitus is also worse than before surgery. I'm hoping that is just during the healing process, but I'm skeptical. So much for thinking I was lucky and had a shot at getting rid of my tinnitus.

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Hang in there and good luck!

 

[Rb86]

To be honest I just had osteoma surgery to try and get rid of my tinnitus. I'm pretty bad off at the moment. So I didn't ask a lot of questions. I'll ask more though at the appointment.

My tinnitus is also worse than before surgery. I'm hoping that is just during the healing process, but I'm skeptical. So much for thinking I was lucky and had a shot at getting rid of my tinnitus.

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Sorry buddy. I'm going to pray for you - I have a feeling your body and tinnitus will calm down with time. You just had the surgery. Hang in there. So far the only thing I know? Mine is worse if I'm hanging around and not engaged in something. Tinnitus is the get your butt out of bed, get outside and get busy disease so far. Way easier said than done.

 

[all to gain]

I don't think I'll be able to say much more, but I'm moving forward with this trial. I'll be going back to my local center to get my my shot soon. 50/50 chance of getting the drug or placebo.

They said no one had gotten worse from OTO-311, and some people had actually gotten better. They didn't know exactly how many, how much it helped or for how long, or maybe they couldn't say it, but there were some positive results.

Good luck! If you get the placebo do you then get a go with the real thing after the study?

 

[all to gain]

So far the only thing I know? Mine is worse if I'm hanging around and not engaged in something. Tinnitus is the get your butt out of bed, get outside and get busy disease so far. Way easier said than done.

Yep, way easier said than done. This thing sucks.

 

[all to gain]

Yeah it makes no sense to me. I emailed them last night basically saying the medical community doesn't even know enough about tinnitus to qualify somebody based on bilateral or unilateral conditions. Asked them why. Doubt I get a response

Did you actually apply for the clinical trial?

Even if you have it in both ears why can't you just ask to have it done in only one ear?

In fact, how would they know if you have it in one ear or not unless you tell them?

 

[all to gain]

The more I read the more seems like all future "promising treatments" in the pipeline are going to be failures and useless to treat tinnitus...

Sad.

I feel like this.

Even if they are successful we will probably have to wait longer in the UK and Europe to get our hands on the US stuff.

 

[ChrisBoyMonkey]

Good luck! If you get the placebo do you then get a go with the real thing after the study?

I don't think so, I asked and they said they'll check but from the paperwork it said they won't be doing that.

 

[Rb86]

Did you actually apply for the clinical trial?

Even if you have it in both ears why can't you just ask to have it done in only one ear?

In fact, how would they know if you have it in one ear or not unless you tell them?

Yes. Read my posts. I was turned down based on the phone interview.