Otonomy OTO-313 — Treatment of Tinnitus

[Brian Newman]

And this is why the people participating in these trials for the greater good do really deserve some credit.

Without the "test rats" there would be no treatments or cures for anybody for anything.

Very true. I'm thankful people are doing the trials. It helps research and brings us closer to something.

 

[Brian Newman]

I hope you reconsider enrolling in the trial. Here's why:

Even if you get the placebo, your participation would help to get the drug to market sooner.

So if the drug works, you either win by getting the drug early in the study, or if you get the placebo then you win by getting the drug after the study.

Alternatively, if everyone avoids participating in the study then no-one will ever get the drug.

I strongly considered it. If I didn't have a hole in my right cochlea and severe noxacusis in my left ear, plus hell distortions in both, I would gladly do it. My shit is so bad that I most likely need a blood patch and am avoiding it because of the repercussions. I am teetering on edge of getting so bad I'm gonna end it. I don't think I'm a good candidate. I have moderate tinnitus and hear it a lot. It does not bother me at all. Tinnitus is the least of my worries right now.

Hoping if I did it, OTO-313 would help damaged nerves/synapses, theoretically helping my noxacusis, but it's a long shot.

 

[Ehren M]

I strongly considered it. If I didn't have a hole in my right cochlea and severe noxacusis in my left ear, plus hell distortions in both, I would gladly do it. My shit is so bad that I most likely need a blood patch and am avoiding it because of the repercussions. I am teetering on edge of getting so bad I'm gonna end it. I don't think I'm a good candidate. I have moderate tinnitus and hear it a lot. It does not bother me at all. Tinnitus is the least of my worries right now.

Hoping if I did it, OTO-313 would help damaged nerves/synapses, theoretically helping my noxacusis, but it's a long shot.

I completely respect where you're at. I didn't mean to insinuate that I know what's best for ya, and I'm sorry if it came across that way.

I really hope your situation improves.

Cheers.

 

[canteven]

I don't know if this question was answered already... but what does it mean when they say they had positive results in Phase 1/2?

Does it mean they have had people who have reduced their tinnitus?

What does "positive results" mean?

 

[Gb3]

How's @Sentinel doing?

 

[buttercake]

Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients with Moderate to Severe, Persistent Tinnitus - A Phase 1/2 study

 

[PortugalTheMan]

Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients with Moderate to Severe, Persistent Tinnitus - A Phase 1/2 study

Great news for all of us with tinnitus

I've seen many people without hope on OTO-313, but this is what will give us some relief. I believe that both those who have had tinnitus for 6 months and those who have had tinnitus for 5 or 10 years will find relief here.

 

[Fields]

Since bilateral tinnitus comprises a significant portion of tinnitus patients (35), testing bilateral intratympanic administration will be a future goal for OTO-313 clinical development.

For those worried about OTO-313 only being intended for unilateral tinnitus.

Thanks for sharing @buttercake, very interesting read.

 

[Nobody19]

Interesting, but I don't want to get too optimistic. Frequency Therapeutics also published their Phase 1 results which looked promising at the time.

 

[Stacken77]

I believe that both those who have had tinnitus for 6 months and those who have had tinnitus for 5 or 10 years will find relief here.

I really hope that is true, but I'm a bit doubtful that it would benefit long-term chronic sufferers since it doesn't aim to eliminate the problem in the brain. It would be interesting if they could try it on long-term sufferers, since the study had a cap of 6 month duration.

 

[buttercake]

David Baguley is among the authors. He tweeted a few hours ago: "[...] The benefits for #tinnitus were modest, but clinically significant and sustained. Further trials needed: drug not yet clinically available."

 

[Exit]

I really hope that is true, but I'm a bit doubtful that it would benefit long-term chronic sufferers since it doesn't aim to eliminate the problem in the brain. It would be interesting if they could try it on long-term sufferers, since the study had a cap of 6 month duration.

I agree @Stacken77
Perhaps you know this, but they did patients up to a year in the extended trial going on now.

They're going to release results for 0-6 months and 6-12 months, probably in about a year.

 

[Gb3]

Great news for all of us with tinnitus

I've seen many people without hope on OTO-313, but this is what will give us some relief. I believe that both those who have had tinnitus for 6 months and those who have had tinnitus for 5 or 10 years will find relief here.

They stated this in the Tinnitus Talk Podcast.

 

[Gb3]

For those worried about OTO-313 only being intended for unilateral tinnitus.

They won't do this if they want to get it to market. It will be definitely something you can try if it gets approved.

 

[Pharz]

Otonomy Announces Publication of Phase 1/2 Trial Results Showing Tinnitus Improvement in Patients Receiving OTO-313

 

[Wrfortiscue]

So what is the drug actually doing?

 

[star-affinity]

So what is the drug actually doing?

My understanding is that it contains gacyclidine which reduces the action of NMDA receptors that reside in neurons (i.e. nerve cells). I think the idea is that the NMDA receptors can "overreact" with (some forms of?) tinnitus and therefore "calming them down" could also calm down the tinnitus.

Not sure if that makes sense and I could be wrong.

Anyway, I'm wondering if there will be any downside to taking OTO-313 if one has some hearing loss? Thinking if it could affect any future treatments to generate hair cells and/or synapses which would hopefully also help the tinnitus.

Hopefully no downside to get OTO-313.

Edit:
Seems I wasn't too far off:

OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections.

Otonomy Announces Publication of Phase 1/2 Trial Results Showing Tinnitus Improvement in Patients Receiving OTO-313

 

[Nobody19]

So what is the drug actually doing?

From their press release:

OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections. OTO-313 utilizes a novel, patent-protected formulation technology to provide several weeks of gacyclidine drug exposure in the inner ear following a single intratympanic injection.

 

[Wrfortiscue]

From their press release:

OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections. OTO-313 utilizes a novel, patent-protected formulation technology to provide several weeks of gacyclidine drug exposure in the inner ear following a single intratympanic injection.

Thank you. Do you know if there has been any negative side effects? This is good news for some, including myself.

 

[Wrfortiscue]

My understanding is that it contains gacyclidine which reduces the action of NMDA receptors that reside in neurons (i.e. nerve cells). I think the idea is that the NMDA receptors can "overreact" with (some forms of?) tinnitus and therefore "calming them down" could also calm down the tinnitus.

Not sure if that makes sense and I could be wrong.

Anyway, I'm wondering if there will be any downside to taking OTO-313 if one has some hearing loss? Thinking if it could affect any future treatments to generate hair cells and/or synapses which would hopefully also help the tinnitus.

Hopefully no downside to get OTO-313.

Edit:
Seems I wasn't too far off:

OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections.

Otonomy Announces Publication of Phase 1/2 Trial Results Showing Tinnitus Improvement in Patients Receiving OTO-313

Thank you. Yeah I'm wondering about side effects. Otherwise I'm all in. 6 months in for new trauma.

 

[Nobody19]

The study that someone linked to in this page talks of no serious side effects.

 

[aorelia]

Thank you. Yeah I'm wondering about side effects. Otherwise I'm all in. 6 months in for new trauma.

I was interested in going in and asked some questions. I was told "one subject did experience some worsening of tinnitus which was categorized as mild, and another experienced some mild hearing loss, which then resolved 5 days after onset."

 

[EkkoMusic]

I was interested in going in and asked some questions. I was told "one subject did experience some worsening of tinnitus which was categorized as mild, and another experienced some mild hearing loss, which then resolved 5 days after onset."

Were these subjects from the OTO-313 group or the placebo group?

 

[Gb3]

The study that someone linked to in this page talks of no serious side effects.

The other side effects occurred with the placebo according to the podcast interview.

 

[Diesel]

I was interested in going in and asked some questions. I was told "one subject did experience some worsening of tinnitus which was categorized as mild, and another experienced some mild hearing loss, which then resolved 5 days after onset."

This means nothing. They could have got placebo or OTO-313.

 

[Bambam0]

I know I should scroll through the thread, but what's the best possible release date for this?

 

[Exit]

2025...?

OTIC is up from $1.1 to $2 without any news

 

[Sentinel]

How's @Sentinel doing?

Fluctuating a bit more, but always returning to the new low level during the day. Sometimes I wake up and it's worse and then I get up and move around and it dissipates, sometimes before going to bed it's louder and quiet in the morning. Frankly, because it's at a lower level most of the time when it is louder I perceive it as being worse than it is because I have to do my journal entries for the study every night. I feel like if I wasn't monitoring it all the time I'd notice it less overall but that's part of the deal. When it's really low and I'm in a quiet room I have to almost search for it to be able to hear it, which was NOT the case before.

My participation in the study ends at the end of this month, and I was injected in early July and am clearly still experiencing positive effects which I think is pretty awesome. It may have had a permanent effect on my tinnitus which is relieving. I feel like I have more control over it in a strange way. I'm ready to stop logging my tinnitus every night and just enjoy this new normal for as long as it lasts. It's given me the opportunity to feel like I can move past it.

Still far preferable to the way it was before even with fluctuations.

I'm happy.

 

[Mica Rambin]

Fluctuating a bit more, but always returning to the new low level during the day. Sometimes I wake up and it's worse and then I get up and move around and it dissipates, sometimes before going to bed it's louder and quiet in the morning. Frankly, because it's at a lower level most of the time when it is louder I perceive it as being worse than it is because I have to do my journal entries for the study every night. I feel like if I wasn't monitoring it all the time I'd notice it less overall but that's part of the deal. When it's really low and I'm in a quiet room I have to almost search for it to be able to hear it, which was NOT the case before.

My participation in the study ends at the end of this month, and I was injected in early July and am clearly still experiencing positive effects which I think is pretty awesome. It may have had a permanent effect on my tinnitus which is relieving. I feel like I have more control over it in a strange way. I'm ready to stop logging my tinnitus every night and just enjoy this new normal for as long as it lasts. It's given me the opportunity to feel like I can move past it.

Still far preferable to the way it was before even with fluctuations.

I'm happy.

This is great news.

 

[ColinUK]

Is 43% considered a good result?

Not that I'm pessimistic or anything

But if only 43% got an improvement and this is their ideal patient in the acute phase, does it really offer much hope to any long term sufferer which we all will be by the time this is released which they are less hopeful about it working for anyway?

I mean if Dr. Shore's trial reports back only 40% saw improvement, I would consider that pretty poor or is it different for drugs?