AM-101 TACTT1 Results Released

Very happy for you Bart!

I contacted Auris with the question if am-101 is proven to be/not to be helpful in chronic Tinnitus and if they completely thrown out the idea, I also stated that i have had my Tinnitus for 5 years now.

reply;


We will evaluate efficacy in a post-acute stage as part of our phase III clinical trial in Europe.


Kind regards,


Thomas Meyer

not much information though it seems they keep the possibility open. So they must have concluded that the effect of the drug does n`t diminish when reaching 3 months post onset. fingers crossed.
 
I have some relatives in gerymany, can i just lie and tell i live in germany? :p (I live in sweden)

Sure you can but they probably ask for your documents and secondly, when complications appear and you are in Sweden at the time then its really your loss. Therefore wouldn't advise you to do that. Also, your profile says that you have had tinnitus since 2005 so you dont qualify anyway?
 
Very happy for you Bart!

I contacted Auris with the question if am-101 is proven to be/not to be helpful in chronic Tinnitus and if they completely thrown out the idea, I also stated that i have had my Tinnitus for 5 years now.

reply;


We will evaluate efficacy in a post-acute stage as part of our phase III clinical trial in Europe.


Kind regards,


Thomas Meyer

not much information though it seems they keep the possibility open. So they must have concluded that the effect of the drug does n`t diminish when reaching 3 months post onset. fingers crossed.

What does he mean with post-acute stage?
I do understand that the brain rememebr the tinnitus and the treatment would not help because it solves only the core problem in the ear (ore am I wrong?). But, if you cure the core "problem", than treating tinnitus might be easier done by just training the brain to ignore/forget the sound (like with vns). I mean, if you would combine vns with AM-101 i belive chronic tinnitus is curable.
 
Sure you can but they probably ask for your documents and secondly, when complications appear and you are in Sweden at the time then its really your loss. Therefore wouldn't advise you to do that. Also, your profile says that you have had tinnitus since 2005 so you dont qualify anyway?

Yes i got tinnitus 2005, but it got worse this summer, like much worse due loud noise trauma. Maby AM-101 can help me treat the damage i got this summer.
How would the know when I got my tinnitus ;P ............ I am desprate, tinnitus has ruined my life in so many ways. I couldent care less if I got tinnitus when i reach 40+ age, cuz by than iv probably lived my life, but i got it when i was 10 years old and im 19 now, not fun having tinnitus in this age.......... :( :(
 
Yes i got tinnitus 2005, but it got worse this summer, like much worse due loud noise trauma. Maby AM-101 can help me treat the damage i got this summer.
How would the know when I got my tinnitus ;P ............ I am desprate, tinnitus has ruined my life in so many ways. I couldent care less if I got tinnitus when i reach 40+ age, cuz by than iv probably lived my life, but i got it when i was 10 years old and im 19 now, not fun having tinnitus in this age.......... :( :(

I understand your frustration. But unfortunately if you decide to participate then that will make the results of the survey inaccurate. For scientific plausibility I would not advise to lie and mess with the results. If smth goes wrong then that could mean that the drug will never reach the market.
Also, you are not going to live with tinnitus for decades. If the trials of AM101 are successful, it will probably be on the market in 4-5 years from now and as you said yourself, it could help with "spikes". In addition to this, yes Am101 is probably the 1st drug to be on the market. But many studies are held for chronic tinnitus as well. Not much of a consolation, but its the best we have.
 
I understand your frustration. But unfortunately if you decide to participate then that will make the results of the survey inaccurate. For scientific plausibility I would not advise to lie and mess with the results. If smth goes wrong then that could mean that the drug will never reach the market.
Also, you are not going to live with tinnitus for decades. If the trials of AM101 are successful, it will probably be on the market in 4-5 years from now and as you said yourself, it could help with "spikes". In addition to this, yes Am101 is probably the 1st drug to be on the market. But many studies are held for chronic tinnitus as well. Not much of a consolation, but its the best we have.

Given the length of time these trials will be run, my own familiarity with FDA regulatory approvals and whatnot, I don't think it will take 4-5 years to get to market (this is from a US point of view, of course). It is the only drug that treats a given condition, literally. That could speed along it's approval. Most of these Phase III trials are set to be completed in 2015. Auris is hurrying to get this to market (as fast as they can). I think that if the results are good, we are looking at a 2.5 year time window for market approval (at worst). Then again, that's my guess.
 
Given the length of time these trials will be run, my own familiarity with FDA regulatory approvals and whatnot, I don't think it will take 4-5 years to get to market (this is from a US point of view, of course). It is the only drug that treats a given condition, literally. That could speed along it's approval. Most of these Phase III trials are set to be completed in 2015. Auris is hurrying to get this to market (as fast as they can). I think that if the results are good, we are looking at a 2.5 year time window for market approval (at worst). Then again, that's my guess.

Well that would be very nice:) On the other hand, I think it might on the market in bigger countries such as the US. In Estonia you are only considered sick when your heart stops beating so I guess for us it will take longer:(
 
I understand your frustration. But unfortunately if you decide to participate then that will make the results of the survey inaccurate. For scientific plausibility I would not advise to lie and mess with the results. If smth goes wrong then that could mean that the drug will never reach the market.
Also, you are not going to live with tinnitus for decades. If the trials of AM101 are successful, it will probably be on the market in 4-5 years from now and as you said yourself, it could help with "spikes". In addition to this, yes Am101 is probably the 1st drug to be on the market. But many studies are held for chronic tinnitus as well. Not much of a consolation, but its the best we have.

4-5 years :banghead: :arghh: and its not even for chronic tinnitus hmm, I have more hope in AUT00063..
After summer I am gonna start reading biomedical in university and if there is no cure for chronic tinnitus by the time i finish my studies, than im gonna find it!
 
...and if there is no cure for chronic tinnitus by the time i finish my studies, than im gonna find it!

That's the spirit! I also find Autifony approach more appealing, but I wouldn't expect them to present ready solutions any time soon, given that they are only at the first stage of trials.
 
It has been confirmed that my first appointment for the AM-101 trial is on the 20th, where I will be evaluated by an audiologist. I will keep all of you updated throughout the procedure.

That's great news, I'm looking forward to hearing about your experience. Thanks for taking the plunge for all of us! Is it TACTT 2 or TACTT 3 you'll be participating in?
 
What does he mean with post-acute stage?
I do understand that the brain rememebr the tinnitus and the treatment would not help because it solves only the core problem in the ear (ore am I wrong?). But, if you cure the core "problem", than treating tinnitus might be easier done by just training the brain to ignore/forget the sound (like with vns). I mean, if you would combine vns with AM-101 i belive chronic tinnitus is curable.
I think the whole acute vs chronic is still an assumed condition because there isn`t any cure or treatment yet that can make a division between these two. Like adhd is an assumed condition, there is no way to prove it, it is accepted as such. So I feel that am-101 will mark a new era because this will pin point to certain degrees when it stops helping someone and thus prove this person has reached a state of `chronic` tinnitus.

also i think am-101 will help, or not, and does not need any combined treatments ... but w`ll wait till they come with it on the market and test it out! :)
 
This might be a stupid question, but i understood that in this treatment you get some injections to the ear where tinnitus is, how about then when both ears are ringing? Does it cost more than when you have injections just in one ear?
 
This might be a stupid question, but i understood that in this treatment you get some injections to the ear where tinnitus is, how about then when both ears are ringing? Does it cost more than when you have injections just in one ear?

These are Phase III clinical trials. Participation in the trial will not cost you anything, as it is experiment (albeit the last stage before a product goes commercial). That means a safety profile has generally been established, but not tested in large numbers of people. The product at this stage should be safe. To my knowledge they are treating both ears (if needed) in patients for these Phase III clinical trials.
 
These are Phase III clinical trials. Participation in the trial will not cost you anything, as it is experiment (albeit the last stage before a product goes commercial). That means a safety profile has generally been established, but not tested in large numbers of people. The product at this stage should be safe. To my knowledge they are treating both ears (if needed) in patients for these Phase III clinical trials.

I am curious, how expensive will be this treatment in commercial stage. I estimate it around $1000 for one ear.
 
I am curious, how expensive will be this treatment in commercial stage. I estimate it around $1000 for one ear.

Well, that is for the marketing folks at Auris (and their partners) to decide. My guess is it will be fairly expensive starting out, as we're a captive market and there is no competition. I don't see any reason why insurance would not cover the procedure, as long as a medical professional recommends it as a treatment regimen. It may cost a good amount anyway, because it is technically a surgical procedure.
 
I don`t think it will be that expensive because it is a cheap product and fairly easy way of administration. It all depends if your local ENT can do it or if there will be like Auris linked special new treatment centers or people that do it on demand on special days in the week or so. I suspect it will be covered in the countries where the Government that cares about the well-being of their people ...
 
I wonder about insurance coverage though. I think insurance companies would cover acute and post acute, but chronic people might not get covered.

And they can prove your "chronic" condition how? ;)
 
And they can prove your "chronic" condition how? ;)
I was thinking the same thing... When this comes out on the market how would they be able to say only for accute or covers only accute T... Think they would be smarter to not do that cause they know there gonna get overloaded with tons of chronic T people that say theres is accute.. And no way to prove either!
 
So is this the most promising treatment for tinnitus in the moment? And it will take 4-5 years to have it available for everybody? I have to say: time is too long for those who wait, but I guess that it's better than 10 years... I just have to hope that they will discover new treatments in my lifetime, It would be nice to hear silence before I'm 70 and suffering from dementia, then I wouldn't even remember that I suffered from tinnitus 50 years... ;)
 

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