Otonomy OTO-313 — Treatment of Tinnitus

[Wrfortiscue]

You can only use OTO-313 within 6 months? Or does it matter how long you've had tinnitus for? Either way that's good news or at least gives hope.

 

[Gb3]

You can only use OTO-313 within 6 months? Or does it matter how long you've had tinnitus for? Either way that's good news or at least gives hope.

They don't know yet. This trial let people in that had tinnitus up to a year in.

 

[Foamearplugssuck]

I have so many questions now. Does OTO-313 help with hyperacusis? Will it allow me to go to concerts again? Could I potentially use headphones within the next five years?

...Deep breaths. Gotta stay patient until those trial results come back. Nothing is guaranteed until then.

 

[Exit]

You can only use OTO-313 within 6 months? Or does it matter how long you've had tinnitus for? Either way that's good news or at least gives hope.

Originally they accepted participants that had had tinnitus for less than 6 months.

They bumped it up to 12 months in this study.

Yes if it works, it's good news anyway because of the cash flow and many companies getting geared up on the flow.

I wanted to put a question here:

If OTO-313 works well for those who have had tinnitus for less than 12 months, I don't see the logic in it only being effective up to 12 months and not, for example, up to 40 months...?

Anyone care to contribute?

I don't buy the whole, tinnitus settles in your brain arguments.

Nor do I agree with every tinnitus case lasting less than 12 months to be inflammatory based.

 

[tommyd87]

Would be awesome if they would consider licensing this delivery method to other companies…

Otonomy has effectively done this already with Kyorin for OTO-6XX, as they have allowed Kyorin to have their medicine trialled through the FDA processes whilst using Otonomy's medicine delivery technique.

 

[tommyd87]

You can only use OTO-313 within 6 months? Or does it matter how long you've had tinnitus for? Either way that's good news or at least gives hope.

Having tinnitus for 6 months is the rough or approximate time frame that Otonomy is testing this medicine for.

Depending on the success of this trial, there is one of two things which could happen

> Otonomy releases this medicine successfully as it passed trials for this use and as a result it can be tried off-label for other uses also.

> Otonomy expands the trials to test for other indications such as long-term tinnitus too.

 

[Aaron91]

They are gonna do some more bloodwork for some unfathomable reason and I'll probably fill out more TFI forms to track the course of my progress so that Otonomy has data..[/USER]

Bloodwork is there to check for systemic levels of the drug in correlation with any adverse events. Hope you get continued relief!

 

[Lucifer]

I have so many questions now. Does OTO-313 help with hyperacusis? Will it allow me to go to concerts again? Could I potentially use headphones within the next five years?

...Deep breaths. Gotta stay patient until those trial results come back. Nothing is guaranteed until then.

Probably not but PIPE-505 or FX-322 may help depending on what is causing hyperacusis, whether it's the synapses, IHCs or OHCs.

 

[Gb3]

This is my opinion just from what I have read and heard. Honestly no one knows if OTO-313 will only work for acute or chronic tinnitus. I don't believe tinnitus settles in the brain. I just think that is the endpoint that reacts and creates the sound. The brain is not getting the input it needs or a circuit is broken causing the brain neurons the misfire. The main reason why I believe this is when we see people who have had tinnitus for years but whose tinnitus vanished when they get implanted with a cochlear implant. You fix the root problem or find something that can calm down the faulty circuit, and the tinnitus should settle or stop.

 

[Lucifer]

This is my opinion just from what I have read and heard. Honestly no one knows if OTO-313 will only work for acute or chronic tinnitus. I don't believe tinnitus settles in the brain. I just think that is the endpoint that reacts and creates the sound. The brain is not getting the input it needs or a circuit is broken causing the brain neurons the misfire. The main reason why I believe this is when we see people who have had tinnitus for years but whose tinnitus vanished when they get implanted with a cochlear implant. You fix the root problem or find something that can calm down the faulty circuit, and the tinnitus should settle or stop.

Same thing with hyperacusis as well. Fix the root cause and it will go away. Either hair cell or synapse regeneration should do the trick.

 

[Paulmanlike]

If you don't believe tinnitus settles in the brain, watch Josef Rauschecker at his TED Talk to understand why this is a good theory.

This is one of the reasons why tinnitus is so difficult to treat. Don't underestimate the complexity of it.

If OTO-313 fails, which it likely will, I would imagine drugs that influence the KV channels will be our only help like with revamped Trobalt, rather than any drugs accepting the ear/cochlear.

 

[Paulmanlike]

@TrevorSanders, I agree with @Gb3[/USER.

I didn't mean to scare you off with my post about being sick man I shouldn't have posted it as it didn't pertain to the injection. I hope you still have the chance to get the drug.

No hyperacusis ever.

I would say it went from a 7/10 to a 2-3/10.

It was quiet on the day of the injection but it got louder and when I was sick before I got better it was extremely loud. I did have fluctuations but it never was this low ever.

In a year or so.

It's mostly from gunshots. Prolonged gunfire in September of last year and a single shot in November while hunting, developed it in December. It's unilateral but I sorta hear it in the center of my head and my right ear.

I have a follow-up appointment with the clinic in early August and September with my last visit being in October. They are gonna do some more bloodwork for some unfathomable reason and I'll probably fill out more TFI forms to track the course of my progress so that Otonomy has data.

As far as buying stock, it's only $1.79 right now so you don't have a ton to lose I suppose but I wouldn't take stock advice from a novice like me lol.

Buying stock in this is like playing Russian roulette. It is not investing, it's a gamble.

Although I'm pleased for your success, I think I can conclude that even if you got the real drug, I can not write this off as it definitely working. Tinnitus can and does subside, although the longer cases tend to be with us for life. That said, I have heard of cases disappearing after many years.

You said it definitely works and I'm not saying it definitely does not, but that is one hell of an assumption you're making.

 

[Padraigh Griffin]

If you don't believe tinnitus settles in the brain, watch Josef Rauschecker at his TED Talk to understand why this is a good theory.

This is one of the reasons why tinnitus is so difficult to treat. Don't underestimate the complexity of it.

If OTO-313 fails, which it likely will, I would imagine drugs that influence the KV channels will be our only help like with revamped Trobalt, rather than any drugs accepting the ear/cochlear.

Doesn't Susan Shore, the world's most experienced tinnitus researcher, suggest it is caused by hyper excitability of fusiform cells (and perhaps bushy cells) in the dorsal cochlear nucleus (and perhaps the dorsal ventral nucleus). Isn't that what Trobalt works on too?

 

[rei]

If you don't believe tinnitus settles in the brain, watch Josef Rauschecker at his TED Talk to understand why this is a good theory.

This is one of the reasons why tinnitus is so difficult to treat. Don't underestimate the complexity of it.

If OTO-313 fails, which it likely will, I would imagine drugs that influence the KV channels will be our only help like with revamped Trobalt, rather than any drugs accepting the ear/cochlear.

Settles or occurs? How could anyone really know since hearing regeneration hasn't been done yet, which is the ultimate test. As impressive as his TED Talk is, theories aren't facts.

 

[canteven]

Buying stock in this is like playing Russian roulette. It is not investing, it's a gamble.

Although I'm pleased for your success, I think I can conclude that even if you got the real drug, I can not write this off as it definitely working. Tinnitus can and does subside, although the longer cases tend to be with us for life. That said, I have heard of cases disappearing after many years.

You said it definitely works and I'm not saying it definitely does not, but that is one hell of an assumption you're making.

Paul, what cases have you heard of it disappearing after many years? And were these cases noise induced?

 

[tommyd87]

If you don't believe tinnitus settles in the brain, watch Josef Rauschecker at his TED Talk to understand why this is a good theory.

This is one of the reasons why tinnitus is so difficult to treat. Don't underestimate the complexity of it.

If OTO-313 fails, which it likely will, I would imagine drugs that influence the KV channels will be our only help like with revamped Trobalt, rather than any drugs accepting the ear/cochlear.

Rauschecker hasn't had his theories totally proven to be facts yet though and there tends to be evidence which also does not support his theories as well.

We also know OTO-313 is not a hearing regeneration treatment.

 

[Foamearplugssuck]

Paul, what cases have you heard of it disappearing after many years? And were these cases noise induced?

I am not Paul, but my photo teacher did tell me that his uncle got tinnitus after coming off of an airplane. He had had it for six years or so, then one day he his ears just randomly popped and his tinnitus vanished. Obviously that was not noise-induced tinnitus though. Sigh.

 

[Damocles]

I am not Paul, but my photo teacher did tell me that his uncle got tinnitus after coming off of an airplane. He had had it for six years or so, then one day he his ears just randomly popped and his tinnitus vanished. Obviously that was not noise-induced tinnitus though. Sigh.

Don't put yourself down like that; you're as much Paul as any of us!

...except Paul; who could very well be the Paulest of all...

 

[Paulmanlike]

Paul, what cases have you heard of it disappearing after many years? And were these cases noise induced?

It happens, random anecdotes on the internet. Who knows why this is. I could spend all day on my own theories and theories of Dr. Shore and Prof. Rauschecker. The truth is; they don't really know.

 

[Paulmanlike]

Doesn't Susan Shore, the world's most experienced tinnitus researcher, suggest it is caused by hyper excitability of fusiform cells (and perhaps bushy cells) in the dorsal cochlear nucleus (and perhaps the dorsal ventral nucleus). Isn't that what Trobalt works on too?

She does and that is her theory. Regarding Trobalt that is unrelated to her theory, Trobalt was a serendipitous discovery that it helped tinnitus; Dr. Shore is working in bimodal neuromodulation around her theory.

I never read much about Trobalt, but it has something to do with potassium channels in brain. Again, all theories to why some people saw lowered tinnitus. But it was withdrawn and it turned them into Smurfs with milky man boobs. Personally, I wouldn't mind being Blue and having boobs to play with for lower tinnitus, but allegedly it's not a nice side effect.

 

[anton40]

I am sure tinnitus is a brain issue, personally I don't have any problems with my hearing, but I have a really high beep in my head. It has destroyed my life completely.

 

[star-affinity]

I am sure tinnitus is a brain issue, personally I don't have any problems with my hearing, but I have a really high beep in my head. It has destroyed my life completely.

I'm pretty sure it can be both.

Tinnitus can get triggered in conjunction with hearing loss. I actually heard it happen, waking up just before the tinnitus onset while listening to music during sleep to mask my other two tinnitus sounds. My ear did this two-second "warped chirp" then the tinnitus started.

My other two older tinnitus sounds to my knowledge don't correlate to any hearing damage, at least it doesn't show up in an audiogram on that ear. The new one does.

Besides, what hinders the tinnitus from originating in the cochlea despite the hearing being seemingly unaffected? Maybe some neurons and hair cells can cause the tinnitus while still doing a good job with hearing?

But sure – maybe sometimes it's only a neurological thing in the brain, nothing to do with the ear, but I don't think we can conclude it's always like that.

 

[Exit]

I have many ear problems after acoustic trauma, so you can say I have lots of experience.

It certainly feels like a physical cochlea problem, although I definitely feel it as a brain problem as well since it evolves.

I'm not betting even a dollar on it settling in the brain. How come it evolves with time even years after onset if it settles?

What about those whose tinnitus greatly improves with cochlear implants or even hearing aids...?

Well, we'll have the answers in about 20 years or less.

Logically it should be easier to treat tinnitus with regenerative medications than with OTO-313.

But if OTO-313 helps acute cases, then I really have trouble seeing it not helping those longtime noise-induced tinnitus sufferers.

 

[Gb3]

I am sure tinnitus is a brain issue, personally I don't have any problems with my hearing, but I have a really high beep in my head. It has destroyed my life completely.

You most definitely have something wrong with your cochlear, or have hearing loss that isn't detectable on an audiogram.

 

[NewLionel]

If this stuff works, I'll get OTO-313 and OTO-413 tattooed on my body. Regardless, glad your tinnitus is lower @Sentinel.

Face tattoo.

I have many ear problems after acoustic trauma, so you can say I have lots of experience.

It certainly feels like a physical cochlea problem, although I definitely feel it as a brain problem as well since it evolves.

I'm not betting even a dollar on it settling in the brain. How come it evolves with time even years after onset if it settles?

What about those whose tinnitus greatly improves with cochlear implants or even hearing aids...?

Well, we'll have the answers in about 20 years or less.

Logically it should be easier to treat tinnitus with regenerative medications than with OTO-313.

But if OTO-313 helps acute cases, then I really have trouble seeing it not helping those longtime noise-induced tinnitus sufferers.

Is there no history of any game changing medicine getting a quick release? Like treatment for COVID-19 or AIDS? Got to be something en route in less than 20 years! I'm hoping something arrives in the next 5 years.

 

[tommyd87]

You most definitely have something wrong with your cochlear, or have hearing loss that isn't detectable on an audiogram.

Not necessarily, there are still those non cochlear sources of tinnitus.

 

[Ehren M]

I am not Paul, but my photo teacher did tell me that his uncle got tinnitus after coming off of an airplane. He had had it for six years or so, then one day he his ears just randomly popped and his tinnitus vanished. Obviously that was not noise-induced tinnitus though. Sigh.

Yea, airplanes suck for ears. I write this as I wait to board an airplane :/

As a little kid (<10 years) I once had severely muted hearing for a week after a flight of only a couple of hours duration.

 

[Justin Mills]

Not necessarily, there are still those non cochlear sources of tinnitus.

Yes but very rare, most of the people on this forum have tinnitus from loud sound exposure, which is most treatable by regenerative therapies such as Pipeline Therapeutics' drugs or OTO-413 that regenerate synapses. It probably would resolve tinnitus caused by ototoxic medication as well.

Moreover, the benefit of these regenerative therapies is NOT just curing tinnitus, it's also about restoring hearing fidelity and clarity! We don't merely want to reverse tinnitus, we want to restore the full clarity of hearing that we had before external insults such as forgetting our earplugs when going to clubs/concerts/hunting etc.

Yes there is some tinnitus that arises from sources other than hearing damage, but those people wouldn't have issues with their hearing. In other words, those people may have sources of tinnitus that are not connected to cochlear damages, and yes, in that case, OTO-313 sounds like the best thing for those few people. But it's important to note the vast majority of us have tinnitus directly caused by cochlear damage.

 

[Gb3]

Not necessarily, there are still those non cochlear sources of tinnitus.

If it's not related to TMJ, pulsatile tinnitus or blood flow issues, it's most likely due to cochlear reasons.

 

[tommyd87]

Yes but very rare, most of the people on this forum have tinnitus from loud sound exposure, which is most treatable by regenerative therapies such as Pipeline Therapeutics' drugs or OTO-413 that regenerate synapses. It probably would resolve tinnitus caused by ototoxic medication as well.

Moreover, the benefit of these regenerative therapies is NOT just curing tinnitus, it's also about restoring hearing fidelity and clarity! We don't merely want to reverse tinnitus, we want to restore the full clarity of hearing that we had before external insults such as forgetting our earplugs when going to clubs/concerts/hunting etc.

Yes there is some tinnitus that arises from sources other than hearing damage, but those people wouldn't have issues with their hearing. In other words, those people may have sources of tinnitus that are not connected to cochlear damages, and yes, in that case, OTO-313 sounds like the best thing for those few people. But it's important to note the vast majority of us have tinnitus directly caused by cochlear damage.

I agree with this. Thus this is why I think that the treatments that deal with hearing issues will far outweigh the benefits overall compared to a treatment that just targets tinnitus solely.