Otonomy OTO-313 — Treatment of Tinnitus

[Exit]

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.

Microsuction is more likely to hurt you. Pain is simple!

 

[bill 112]

The thing is they don't actually HAVE to suction it out. It's just the fastest, most effective way but not necessarily the only way. When I refused suction after that incident, all of a sudden anytime they needed to clear earwax they cleared it manually which, yes, took longer but was far better in terms of ear safety. When they put an earwax softener in my ear, once they were able to manually clean out the ear and clear up the rest with a gauze and cotton, so there are ways to clear it out without suction it's just suction is the "quickest" and "easiest" way for them.

What's scary for me and after seeing it commented here just now is that I am one of those people who can feel pain even after numbing. It started last year and I first noticed it after a trip to the dentist. At first they thought it was an infection because infections block the anaesthesia apparently. Two courses of antibiotics later and I could still feel everything he was doing even after my jaw was loaded to the max with the stuff but hey, if OTO-313 worked, I'd get a needle through my eyeball if I had to.

 

[Darktale]

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.

It makes me think about me and my rheumatologic problems... I have to go from time to time for intra-articular injections of corticosteroids... directly inside the joint (finger, elbow...).

Normally they use first Xilocaine/Lidocaine as an anesthetic agent, which can be ototoxic. Even if the risk is minimal when used for local injection, I prefer to avoid it so everytime I say to the doctor, I will do the injection direct, without the anesthetic...

I must avoid any movement or the needle could hurt for example my tendons...
At the end the doctor always say "dude, you are a real warrior"

 

[NYCGuy]

Microsuction is more likely to hurt you. Pain is simple!

Pain is not the issue. The issue is when you feel severe pain, you will move with a needle inside your ears. Just think of that.

It doesn't matter how tolerant you are to pain, when extreme pain happens, your body reacts automatically.

 

[Exit]

Pain is not the issue. The issue is when you feel severe pain, you will move with a needle inside your ears. Just think of that.

It doesn't matter how tolerant you are to pain, when extreme pain happens, your body reacts automatically.

You have a good point, but whenever someone has got a needle or a knife against me I usually freeze up and do my best NOT to move

Also does it hurt that much? Some Oxycontin usually relaxes you

A good doctor would also be accustomed to people twitching so I think it will be okay? At least better than an acoustic trauma.

After the hole is made in the eardrum, my understanding is they just push the goo out into the ear canal and hopes it sticks around...?

 

[dbeats]

The thing is they don't actually HAVE to suction it out. It's just the fastest, most effective way but not necessarily the only way. When I refused suction after that incident, all of a sudden anytime they needed to clear earwax they cleared it manually which, yes, took longer but was far better in terms of ear safety. When they put an earwax softener in my ear, once they were able to manually clean out the ear and clear up the rest with a gauze and cotton, so there are ways to clear it out without suction it's just suction is the "quickest" and "easiest" way for them.

What's scary for me and after seeing it commented here just now is that I am one of those people who can feel pain even after numbing. It started last year and I first noticed it after a trip to the dentist. At first they thought it was an infection because infections block the anaesthesia apparently. Two courses of antibiotics later and I could still feel everything he was doing even after my jaw was loaded to the max with the stuff but hey, if OTO-313 worked, I'd get a needle through my eyeball if I had to.

I'm guessing the numbing agent is on the eardrum itself? I can't imagine that any ENT would actually remove a numbing agent from the eardrum with a curette? Sounds unlikely considering the risks.

Seems like suction might be the only way.

 

[bill 112]

I'm guessing the numbing agent is on the eardrum itself? I can't imagine that any ENT would actually remove a numbing agent from the eardrum with a curette? Sounds unlikely considering the risks.

Seems like suction might be the only way.

Trust me, they can. It just takes a while. I don't want to be graphic or anything but when they put that earwax softening stuff into my ears, my ear canals were completely blocked by what felt like an oily goo. All of it was removed by hand and the rest was removed with mild irrigation, not the horrible irrigation they normally do, just a mild gentle stream of warm water. It's entirely possible but it just takes a lot longer hence why ENTs etc prefer to use microsuction.

 

[dbeats]

Trust me, they can. It just takes a while. I don't want to be graphic or anything but when they put that earwax softening stuff into my ears, my ear canals were completely blocked by what felt like an oily goo. All of it was removed by hand and the rest was removed with mild irrigation, not the horrible irrigation they normally do, just a mild gentle stream of warm water. It's entirely possible but it just takes a lot longer hence why ENTs etc prefer to use microsuction.

That's completely different. The "earwax softening stuff" normally gets washed out during syringing or a normal shower. With an intratympanic injection, you have a hole in your eardrum, and to my understanding, you need to avoid any liquid going into the middle ear until the eardrum heals.

 

[scotty03874]

That's completely different. The "earwax softening stuff" normally gets washed out during syringing or a normal shower. With an intratympanic injection, you have a hole in your eardrum, and to my understanding, you need to avoid any liquid going into the middle ear until the eardrum heals.

That's correct. I've had 5 different injections through my eardrum. 2 blood patches (for what the doctors thought was a PLF from a trauma to my ear), 2 stem cell injections & 1 steroid injection. It heals in about two weeks. I have first hand knowledge of this...

Pain is not the issue. The issue is when you feel severe pain, you will move with a needle inside your ears. Just think of that.

It doesn't matter how tolerant you are to pain, when extreme pain happens, your body reacts automatically.

Mine were totally painless. When they numb you up, you don't feel a thing but fluid in your ear.

 

[dbeats]

When they numb you up, you don't feel a thing but fluid in your ear.

Did they remove the numbing agent afterward? With suction?

 

[bill 112]

That's completely different. The "earwax softening stuff" normally gets washed out during syringing or a normal shower. With an intratympanic injection, you have a hole in your eardrum, and to my understanding, you need to avoid any liquid going into the middle ear until the eardrum heals.

It is and it isn't completely different. I'm not an expert. I'm going off of my brother's experience who got grommets in years ago and my mate who ruptured his eardrum.

They said they got an injection behind the ear, then stuff was poured in to make it numb, then taken out, so if that's true, what's the risk? They haven't put a hole in the eardrum yet, that comes after the numbing, if I'm not mistaken? The guy with the ruptured eardrum just got the injection, then gauze put in to help the eardrum heal. They didn't pour anything into his ear naturally enough.

I'm kinda going off my and their experience. Maybe @scotty03874 might have more insight into the numbing process pre suction.

 

[Gb3]

I've had 4 injections in my ear. Never once did they suction the numbing agent.

 

[DocTors_94]

I've had 4 injections in my ear. Never once did they suction the numbing agent.

I have also wondered why would they need to do it... It's pointless in my opinion. I don't think you will have systemic Lidocaine absorption through your ear canal skin, at least nothing harmful/toxic levels. It might even help reduce the tinnitus even more for a while, if it truly gets absorbed, who knows.

 

[Brian Newman]

That's correct. I've had 5 different injections through my eardrum. 2 blood patches (for what the doctors thought was a PLF from a trauma to my ear), 2 stem cell injections & 1 steroid injection. It heals in about two weeks. I have first hand knowledge of this...

Mine were totally painless. When they numb you up, you don't feel a thing but fluid in your ear.

Yeah same, I ended up going to Dr. Foster in Miami for a blood patch. It's nothing. I did the microsuction foolishly to get the numbing stuff out but I was fine. That ear was not my catastrophic ear though. Mine took like a month to fully heal but it's fine now.

 

[dbeats]

Yeah same, I ended up going to Dr. Foster in Miami for a blood patch. It's nothing. I did the microsuction foolishly to get the numbing stuff out but I was fine. That ear was not my catastrophic ear though. Mine took like a month to fully heal but it's fine now.

Was the removal of the numbing stuff optional? Could it be different depending on what they are using as a numbing agent?

 

[Brian Newman]

Was the removal of the numbing stuff optional? Could it be different depending on what they are using as a numbing agent?

I think you can get it out another way, maybe light irrigation? Or like a little gauze pad and soak it up. It's not much. I mentioned no microsuction to him and he thought I meant something else. I had my eyes closed because there was going to be a needle going into my ear and I was trying to relax. You could ask the ENT when you do it. Depends on the doctor. They would probably have another alternative. And these people saying not to get the numbing cream, they have no idea what they are talking about. If you don't get it, you will jump out of the chair from pain. I jumped when the numbing stuff got on my eardrum.

It wasn't horrible but it was actually a little painful. When he put the needle in I had bad vertigo for a few seconds. That was a weird feeling. Then I was ok. I actually had mild pain hyperacusis for a month because my eardrum was healing and sounds would give me a little stab here and there. I wasn't worried because it felt like my eardrum. If it was deeper I would have been worried. The microsuction was not horrible, not as bad as the numbing cream. The suction is very quick and fast. I still won't do it again just in case. If I was ok, I think most people should be fine, but everybody is different. I think it's safer not to do microsuction for sure.

 

[scotty03874]

Did they remove the numbing agent afterward? With suction?

No. Dr. Foster out of Miami Beach did not.

 

[Gb3]

@Brian Newman, you jumped when the numbing cream got on your eardrum? You ok bro?

 

[Padraigh Griffin]

Otonomy - Corporate Presentation, March 22, 2022

Exciting times ahead for Otonomy with Phase 2 results and the highly anticipated results from the higher dosing cohort of 12 patients safety study.

Phase 3 in early 2023 with dosing to be decided based on the above results and subsequent meeting with the FDA.

The higher dose is 0.64 mg, which is double that of the original trial which was 0.32 mg.

The four case studies on the presentation are interesting. 63, 47, 37,46 points reduction in TFI.

That is quite impressive. I would certainly take that.

 

[Geatly]

Otonomy - Corporate Presentation, March 22, 2022

Exciting times ahead for Otonomy with Phase 2 results and the highly anticipated results from the higher dosing cohort of 12 patients safety study.

Phase 3 in early 2023 with dosing to be decided based on the above results and subsequent meeting with the FDA.

The higher dose is 0.64 mg, which is double that of the original trial which was 0.32 mg.

The four case studies on the presentation are interesting. 63, 47, 37,46 points reduction in TFI.

That is quite impressive. I would certainly take that.

I hope they bring Phase 3 clinical studies also to EU.

 

[AfroSnowman]

The four case studies on the presentation are interesting. 63, 47, 37,46 points reduction in TFI.

That is quite impressive.

Fingers crossed that is works for chronic tinnitus too.

 

[ploughna]

Exciting times ahead for Otonomy with Phase 2 results and the highly anticipated results from the higher dosing cohort of 12 patients safety study.

Phase 3 in early 2023 with dosing to be decided based on the above results and subsequent meeting with the FDA.

The higher dose is 0.64 mg, which is double that of the original trial which was 0.32 mg.

The four case studies on the presentation are interesting. 63, 47, 37,46 points reduction in TFI.

That is quite impressive. I would certainly take that.

Of course the big question for many of us here is efficacy for long term tinnitus, but otherwise I agree - exciting time ahead and good to see them moving aggressively and with rigor.

 

[Bruce NH USA]

Exciting times ahead for Otonomy with Phase 2 results and the highly anticipated results from the higher dosing cohort of 12 patients safety study.

Phase 3 in early 2023 with dosing to be decided based on the above results and subsequent meeting with the FDA.

The higher dose is 0.64 mg, which is double that of the original trial which was 0.32 mg.

The four case studies on the presentation are interesting. 63, 47, 37,46 points reduction in TFI.

That is quite impressive. I would certainly take that.

Impressive results, indeed.

I wonder, however, if the fact that all of these tinnitus patients in the study had had tinnitus less than one year might have impacted their TFI results? For those who have had it for quite some time, there has been some habituation, typically, so might that impact the scores of a chronic tinnitus sufferer?

Either way, with good results, and a cooperative FDA, this treatment potentially could be available within 2 years or so. I certainly would be happy to give it a try!

 

[Toby1972]

I hope they bring Phase 3 clinical studies also to EU.

Phase 2 was alsy in Germany. But they rejected me (they required unilateral tinnitus, onset less than a year ago), even though I promised them all my BioNTech stock profits, to take me in

 

[Diesel]

Impressive results, indeed.

I wonder, however, if the fact that all of these tinnitus patients in the study had had tinnitus less than one year might have impacted their TFI results? For those who have had it for quite some time, there has been some habituation, typically, so might that impact the scores of a chronic tinnitus sufferer?

Either way, with good results, and a cooperative FDA, this treatment potentially could be available within 2 years or so. I certainly would be happy to give it a try!

So far it looks like the window for treatment is 1 year. Even then, the drug group beat placebo, so it looks promising. I'm not sure what chronic sufferers should expect. At a minimum maybe a good treatment for mitigating further damage from a noise-induced spike. At best, maybe temporary relief or reduction for some subtypes of noise-induced chronic tinnitus.

 

[AfroSnowman]

Is there any pharmaceutical that looks promising for chronic tinnitus, meaning long term?

 

[Padraigh Griffin]

Is there any pharmaceutical that looks promising for chronic tinnitus, meaning long term?

Ebselen.

 

[Diesel]

Is there any pharmaceutical that looks promising for chronic tinnitus, meaning long term?

Depends on the underlying condition. If it's noise and high frequency, then OTO-413 and either of the FX drugs may have an effect. If it's not noise... well...

 

[blamingeverything]

Ebselen.

Interesting, hadn't heard of it. Is any company actively pursuing it?

 

[UKBloke]

Is there any pharmaceutical that looks promising for chronic tinnitus, meaning long term?

Off label use of XEN1101.