AM-101

[Markku]

Auris Medical is behind AM-101 and AM-101 is a drug currently in Phase IIb trial. It's a possible future treatment for tinnitus originating in the inner ear.

The U.S. Study details are here: http://clinicaltrials.gov/ct2/show/NCT00860808

Auris Medical announced today that enrollment has started for its phase II clinical trial with AM-101 for the treatment of acute inner ear tinnitus. The study will enroll a total of 24 patients for further evaluation of the optimum dosing regimen for AM-101 as well as to generate additional pharmacokinetic data. The inclusion criteria require among others that the tinnitus was triggered by an incident of acute noise trauma, sudden deafness, otitis media, inner ear barotrauma or middle ear surgery not more than three months ago. Study participants will receive either AM-101 at 0.81 mg/ml or placebo in a single or triple dose intratympanic injection. Recruitment for the study is expected to be completed before the end of this year.

AM-101 contains a small molecule that selectively blocks N-methyl-D-aspartate (NMDA) receptors. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, exposure to excessive noise, disturbances in inner ear blood supply (anoxia/ischemia), barotrauma, migration of pathogens from the inflamed middle ear into the inner ear, noise/vibration trauma resulting from middle ear surgery or the administration of certain ototoxic drugs. It has been hypothesized that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for abnormal spontaneous "firing" of auditory nerve fibres, which is perceived as tinnitus.
A first clinical trial with AM-101 (phase I/II) showed that intratympanically injected AM-101 was well tolerated by study participants and provided the first indications of therapeutic efficacy. A large double-blind, randomised, placebo-controlled phase IIb clinical trial with AM-101 is currently under way in Germany, Belgium, Poland and the Netherlands to further evaluate the treatment's efficacy and safety. Patient enrollment in the study was completed in early February 2011.

There are lots of more info on AM-101 here on Auris Medical's own site:
http://www.aurismedical.com/product-candidates/am-101


As always, I'm very much looking forward to the results from the trials. So far it's not really 100% certain how long the window of administration is after the onset of tinnitus. The trials exclude people who have had tinnitus for longer than 3 months, but it doesn't necessarily mean the drug won't work for tinnitus cases that are, say, 6 months old?

Correct me if I'm wrong, but it is thought the permanent brain changes occur only after some time, not directly after noise exposure and onset of tinnitus.

If you happen to be a participant in the AM-101 trial, it would be super cool if you shared your experience.

Otherwise feel free to discuss what you think of it.

 

[Dykey Phillips]

In 3 days I am going to do a trial on AM-101...

I have read all that I can and talked to a lot of the people who will be giving me the study drug.

Mind you... I could very well get the placebo. I am a bit skeptical to do this but from the studies they have given me info on... it does show positive results...

Would you do this study if given the chance? Have you heard of any feedback from someone that has done this study?

 

[Dykey Phillips]

So it is 11:00 am ....I got to Gainesville from Orlando Fla. Yesterday. I am at Shands hospital and the trial is being conducted by University of Florida. I am sitting up in my bed. Yesterday they put me through a battery of tests from general health physical to audiology tests, t loudness matching, t questionaire,etc.
Last night I stayed at a nice hotel and met at the hospital at 6:30 am
The process is numb your ear and make an incision..then inject the am101....lay down on your side with your ear up for 30 minutes....then repeat with other ear. Have been able to sit up for about 2hours now. Sounds like I am talking through a tunnel. Treatment makes you feel very dizzy at first and burns. They took blood every 15 minutes the 1st hour and then every 30 minutes the following hour and now every hour.for 6 hours and then I will be allowed to leave. Chicken Salad for lunch....yeah....LOL...
I will let you know the progress.
Taking one for the team.

 

[mock turtle]

yes indeed you are

thanks for being willing to share your experience and what you will find out...obliged

best wishes and good luck

 

[Karl]

Good luck to you! Keep up with the updates. Could be a major breakthrough.

If they put you on a torture rack it would be worth it, if it cures your "T".

 

[mc1]

hey, i got the treatment too, but in a different location, is it possible to call each other and compare experiences? Yours sounds a little different then mine...

 

[Dykey Phillips]

Mc1....Sounds good.
you can can contact me through my email at insurancetoday@hotmail.com
At my office now...still sounds like I am underwater when I talk. t still buzzing. :-{

 

[Tha_b_man]

Thanks for what your doing Dykey...

 

[Dykey Phillips]

O.K. Here is the latest. Today I drove to Gainesville and just got home not that long ago. It is about 240 miles round trip. Got to the hospital this morning and they took all my vitals....I weigh 212.2 in case you need to know that..lol They took my blood and then I left the hospital and went up the road for a ways to see the E.N.T. the same guy that did my injections...said holes in my ears seem to be healing well. few more tests and then on to the audio room for more hearing tests and T masking tests..then a handicap evaluation .
It has been 6 days since I had the am101 done. The few days after the injections my T was at an all time low. I really barely noticed it.......I did have a lot of muffling and cracking in my ears...the medicine {or placebo} looks like clear jelly...Ears seemed to get better after a day or two..even though it takes alot longer for your ears to dissolve the medicine. My t has creeped back up and is maybe even slightly higher than it originally was plus yesterday when I woke up my right ear was completely clogged and kinda fluttering or vibrating..weird and very troubling. So I have seen no real improvement yet......hopefully I can give you guys some news you can use down the road. I will keep you posted.

 

[Molan]

Thanks very much for keeping us all updated Dykey.

 

[Karen]

Dykey --- How are you doing? Do you have anything new to report? Hope it's going well!

 

[Peter]

I opted out of the AM-101 trial LAST MINUTE due to fear of receiving a placebo in North Carolina, but had intertympanic steroid (decadron) injections instead. I live in NYC currently. I am really curious of any updates on your condition?! I acquired tinnitus due to loud noise trauma this past december, just FYI.

 

[daedalus]

Thank you for taking one for the team. I am delighted trials are picking up in the U.S.A.

You may be interested in this testimony: http://www.france-acouphenes.org/forum1/viewtopic.php?t=10658&start=0
It is in French but i have heard the google translation is understandable.

 

[erik]

Thanks Daedalus for post this, very interesting, I wish I could get in one of these trials

 

[Jon Wayne]

In most cases the treatment effect started to appear within a few days from administration and continued to increase over the follow-up period. At Day 90, average reductions from baseline levels exceeded 50% for subjective loudness, ​

this is an excerpt from aurismedical.com​

​

how are you doing now Phillips?​

​

I wonder what would other people who underwent this trial say.​

 

[Louise]

O.K. Here is the latest. Today I drove to Gainesville and just got home not that long ago. It is about 240 miles round trip. Got to the hospital this morning and they took all my vitals....I weigh 212.2 in case you need to know that..lol They took my blood and then I left the hospital and went up the road for a ways to see the E.N.T. the same guy that did my injections...said holes in my ears seem to be healing well. few more tests and then on to the audio room for more hearing tests and T masking tests..then a handicap evaluation .
It has been 6 days since I had the am101 done. The few days after the injections my T was at an all time low. I really barely noticed it.......I did have a lot of muffling and cracking in my ears...the medicine {or placebo} looks like clear jelly...Ears seemed to get better after a day or two..even though it takes alot longer for your ears to dissolve the medicine. My t has creeped back up and is maybe even slightly higher than it originally was plus yesterday when I woke up my right ear was completely clogged and kinda fluttering or vibrating..weird and very troubling. So I have seen no real improvement yet......hopefully I can give you guys some news you can use down the road. I will keep you posted.

Hi Dykey,

Do you have any more news on this?

Thanks,
Louise.

 

[No1FLAgent]

I opted out of the AM-101 trial LAST MINUTE due to fear of receiving a placebo in North Carolina, but had intertympanic steroid (decadron) injections instead. I live in NYC currently. I am really curious of any updates on your condition?! I acquired tinnitus due to loud noise trauma this past december, just FYI.

Hi Peter - how did you your steroid (decadron) injections turn out? did it help you? Thanks. GF

 

[Peter]

the steroid injections helped IMMENSELY! i didnt do anything until week 4-5, and was having audiological headaches up until that point. i only wish i had done it sooner, like day 4-5, NOT weeks. its the best option anyone has, since am-101 is still only one dose and you might receive a placebo. my suggestion to anyone is do the decadron injections FIRST, then enroll in am-101. This way you get both. hope this helps.

 

[erik]

Peter what type of tinnitus do you have and in what way did the Dexamethasone injections help? Reason I ask is because this study from 2005 concluded that it was of no benefit for people with tinnitus of cochlear origin.

 

[Peter]

thats really interesting erik. this definitely was not a placebo effect, trust me. I had done NOTHING prior to that point and had screaming headaches and very loud tinnitus, even after 5 weeks. they were performed by the same doctor in North Carolina who is administering the AM-101 trial. I had a series of 3 injections (once a week in each ear, for 3 weeks). I was flying to North Carolina every week. The decadron injections lowered the noise a lot, although it still remains. Might have reduced any inflamation within the ear. There is still "scarring" left since it didn't completely remove the T.. but trust me it is a lot better.

 

[erik]

Peter, great glad you got some relief. Nice to hear about a treatment working for a change.

 

[TinnitusLogic]

Anyone know if Dykey continued the AM-101 trial? Either way my hats off to him for participating. Way to go Dykey!

 

[Louise]

Peter, do the Decadron injections only work within a certain time period of a person getting T from noise trauma?

 

[J. Wing]

New here and have never heard of the AM-101 trial. Also whats the deal with the Decadron injections? Any info would be appreciated. Tinnitus for 13 years and counting.....Ready for it to end. Also Dykey are you out there? Would like to know how things are going with you.

 

[Aisling]

Did anyone translate the French forum link? What did it say I'm on my iPhone and not very good with technology. Aldo what happened dalky? Did it work out good for him?

 

[mock turtle]

dykey phillips has not updated his condition as far as i know beyond the entries above

i do know he visits this site from time to time

we are left to wonder

of course that is his right to remain private about his current situation

we all wish him well

 

[Markku]

An update from Dykey would be really great.

Good news, bad news, or no news, but an update!

If you spot this, why not tell us your current situation, if you so want, of course.

 

[Fish]

The last time I spoke to Dykey was right after my own AM-101 treatment somewhere in october. I guess this is not a secret anymore - it was Dykey who convinced me to try. I owe him a lot because he was the one to explain everything to me, his own experience and observations.

I won't go into details (If Dykey would like to, he might write it himself) but the drug didn't work too well for him. One thing I noticed though that is worth mentioning:

(...)t still buzzing. :-{

(...)when I woke up my right ear was completely clogged and kinda fluttering or vibrating..weird and very troubling.

It is actually one of the main indications that the patient has received a real drug and not placebo. Majority of patients who got a real drug reported a "vibrating, buzzing" sound that is unpleasant and worrying. This is exactly what happened to me too. I thought it was going to stay and this is why I gave up on a third injection.

 

[Hudson]

It seems that the results from this trial were fairly positive and that Auris is going to move forward with Phase 3 trials. I don't care if this particular drug doesn't apply to me because of how long I've had my tinnitus. The very fact that they're actually making tinnitus drugs and there are drugs entering human trials is a huge step forward. When I got Tinnitus in 2003, nobody was doing research besides seeing how effective TRT was. This is huge.

Hopefully one of Auris' drugs comes through, their AM-111 looks promising for hearing loss as well. I think we've got some good things on the horizon sooner than you folks may think. I believe the real tipping point has been that this condition is no longer a "go home and live with it" - literally hundreds of thousands of veterans have tinnitus and it's costing the VA a massive amount of money. You can bet that's going to get this going much faster.

Another positive thing, is that large pharmaceutical companies are at least looking into tinnitus. That means they know there's money to be made there. If not in a cure, a meaningful treatment. Don't be discouraged when you hear that one drug fails. That's so common in the pharmaceutical industry it's not even funny. It doesn't mean that they're giving up on looking at a condition, it just means they shift their focus a bit. Where there's money to be made.... there's a will to make it.

 

[dan]

Positive results??? Do you have a reference for your conclusion?
It didn't work for Dykey and Fish!