Keyzilen (AM-101) Granted Fast Track Designation by the FDA

Discussion in 'Research News' started by beeeep, Jul 18, 2016.

tinnitus forum
    1. beeeep

      beeeep Member

      Location:
      Germany
      Tinnitus Since:
      ~2000, but real bad since 06/2015
      Cause of Tinnitus:
      Unknown
      Seems like it's almost there...

      Press Release
       
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    2. Karel
      Stressed

      Karel Member

      Location:
      Netherlands
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      acoustic trauma
      So just to check; this drug is completely useless for people who've had T for more than six months or whatever, right? So great news for new sufferers, but I hope they'll invent something for people who've had this condition for years too.
       
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    3. swc5150

      swc5150 Member

      Tinnitus Since:
      06/2012
      Some say yes, other things I've read on it is that it could potentially help chronic T in some people. It's intended for acute, of course, but probably worth a try if you're in the chronic stage.
       
    4. Karel
      Stressed

      Karel Member

      Location:
      Netherlands
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      acoustic trauma
      Hm, ok. Guess we'll have to see how it pans out. It's good news either way, but the more people this can help the better of course.
       
    5. Stakovic

      Stakovic Member

      Tinnitus Since:
      1998
      Cause of Tinnitus:
      Unknown
      They will launch a drug that could make your tinnitus worse, look to Am 101 thread how many people got their T worse after injection.
       
    6. Sebastians

      Sebastians Member

      Tinnitus Since:
      13/10/2015
      Cause of Tinnitus:
      Guitars, loud girls and guns
      It is not the drug itself, but the procedure which holds some risks...
       
    7. linearb
      Psychedelic

      linearb Member Hall of Fame

      Location:
      East Coast USA
      Tinnitus Since:
      1998
      Everything carries risks; if the actual data didn't support the (overall) safety and efficiency of the drug/protocol, then they wouldn't be moving forward.

      Lots of people do things to cope which may be making their tinnitus worse -- look at the number of benzo users we have here. At least AM-101 plausibly does something instead of just being a crappy bandaid that makes your tinnitus worse over time like Xanax is.
       
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    8. beeeep

      beeeep Member

      Location:
      Germany
      Tinnitus Since:
      ~2000, but real bad since 06/2015
      Cause of Tinnitus:
      Unknown
      From the press release:
      "Top-line results from the TACTT2 and TACTT3 trials are expected in August 2016 and in the fourth quarter of 2016, respectively."

      Until then, it's only speculation. As @swc5150 wrote above, there are plenty of posts in the other AM-101 threads where people speculate about the time frame.
       
    9. attheedgeofscience
      Uninvolved

      attheedgeofscience Member Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Childhood
      Cause of Tinnitus:
      Head Injury
      Lots of people engage in activities that will make their tinnitus worse regardless of whether they do so to cope or not. In fact, I would not be the least bit surprised if a number of AM-101 participants of this forum went straight to a rock concert after having had their last injection on day 3 or 5 of the trial.
       
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    10. Sebastians

      Sebastians Member

      Tinnitus Since:
      13/10/2015
      Cause of Tinnitus:
      Guitars, loud girls and guns
      Sorry to bust your misanthropic bubble here, but anyone who *actually* participated in the trial will tell you the spike after injections does not really make you want to rock out for a long time after.
       
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    11. attheedgeofscience
      Uninvolved

      attheedgeofscience Member Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Childhood
      Cause of Tinnitus:
      Head Injury
      I used to think that I was a misanthrope. Then I realized I was just experiencing the world objectively... :D

      I shall not forget the television footage when there - some 20 years ago in Denmark - was a public debate about whether smokers requiring a lung transplant should be put at the back of the waiting list (because the argument from certain politicians was that "it is their own fault"). Now, to "balance the argument" the main television station in Denmark (at the time) had invited a representative from some union to present a counter argument. The only problem was that this was a live news feed - and - by mistake, the television station cut to the reporter doing the interview some 20-30 seconds too early. They therefore "caught" the person who was going to be interviewed early and while he was still smoking a cigarette. This person was himself a lung transplant recipient and now - with his new lungs "installed" - he was abusing them all over again. Can you imagine how that interview went down...?!? :D

      When it comes to human beings, nothing any longer surprises me. And the last fool has not been born either.
       
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    12. Penate

      Penate Member

      Tinnitus Since:
      07/04/2015
      AM-101 in fast track.
       
    13. swc5150

      swc5150 Member

      Tinnitus Since:
      06/2012
      Although I appreciate trial members reporting their results here, those reports likely don't reflect what the actual trial results are showing. AUT063 looked pretty good, if you just took TT member results.
       
      • Agree Agree x 2
    14. Hopeful1
      Depressed

      Hopeful1 Member Benefactor

      Tinnitus Since:
      04/2016
      Cause of Tinnitus:
      Loud Music
    15. mintblue
      Supportive

      mintblue Member

      Tinnitus Since:
      10/2012
      Fucking fantastic news! If it doesn't help a chronic T patient like me at least it will help numerous people in the future who will fall to acute tinnitus. I for one am extremely excited about this :) FDA fast-tracking is almost exclusively used for terminal illness medications related to cancer/etc. It seems having a professional business model and funding behind tinnitus medications CAN help in the lobbying process. Amazing. Crossing my fingers!
       
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    16. Alue

      Alue Member

      Tinnitus Since:
      01/2016
      Cause of Tinnitus:
      Acoustic Trauma
      Been through the trials, I really think it works on a certain sub type of tinnitus and is most likely beneficial very early on. There may be some sub types that it works later on, but only a small percentage. AM101 didn't seem to do much for me. It didn't touch my most bothersome tinnitus, the very high pitched head buzzing that nothing masks, but I did notice I do not get any fleeting tinnitus or other tones in my ear at all since doing the open label round. Regardless, I hope they are successful.

      You and a couple other members have expressed that they wanted this to fail. I couldn't think of anything more myopic than that. Even if AM101 only helps people with acute tinnitus, it's a good thing for the tinnitus community as it would open up the market for tinnitus therapies and provide more funding and more competition for new treatments.

      Another side note I picked up on... not long ago several members joined the forum on the very same day and immediately started talking about bad experiences with AM101. Maybe it's just coincidence, but I found it a little odd.
       
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    17. vegasjon

      vegasjon Member

      Tinnitus Since:
      2012
      I, for one, don't wish for this to fail. And yet -- as a chronic sufferer -- I just can't muster any excitement, either. Not based on what I know, at least.
       
      • Agree Agree x 2
    18. At van der Walt

      At van der Walt Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      loud music,target practice with gun and stress
      I really hope it works and can be used by chronic sufferers too. It is driving me mad.
       
      • Agree Agree x 1
    19. Bobby B
      Fine

      Bobby B Member Benefactor

      Tinnitus Since:
      11/2015
      Cause of Tinnitus:
      long term NIHL and recent acoustic trauma
      From the study where they cut the auditory nerve and about half got cured from T - this shows that there are cases where the T isn't localized in the brain so these folks could potentially still benefit from keyzilen in the chronic phase
       
    20. Ian Mac

      Ian Mac Member

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Vestibular Nueritis, loud music (dubstep)
      A first treatment, something that acknowledges there is a problem and is approved to treat it, is necessary if we will ever get anywhere. This could put T on the map so to speak. Also you will have chronic sufferers who can still try am101 and that will help push things forward as more money goes toward T treatment.
       
    21. Path Maker

      Path Maker Member Benefactor

      Tinnitus Since:
      12/2015
      Cause of Tinnitus:
      acoustic
      I would think that the marketing campaign (television, online and print ads) alone would do a UNIVERSE of good toward public education/awareness. If there is an option, people need to be aware of it so that when tinnitus strikes, they know where to go and what to ask for.

      So this company, if the drug is approved, is going to launch big time marketing.

      This can only be of huge benefit to not only the people who can be helped by this particular drug, but by creating a MUCH greater public awareness, as well as spurring on the other researchers to get in the "game" so to speak. <<--It's no "game," for the sufferers. But if profits motivate the research, and better treatments come, well then!
       
      • Agree Agree x 1
    22. Hottopic29

      Hottopic29 Member

      Tinnitus Since:
      11/13
      Im confused all thee names and trials .. are they using the same drug in them all or differant one in a few .
       
    23. Starlord

      Starlord Member

      Location:
      St. Petersburg, Florida
      Tinnitus Since:
      02/2016
      Cause of Tinnitus:
      Noise induced
      @Hottopic29

      From what I last remember reading the initial/main trial was of 3 groups (two different doses of esketamine or a placebo). Then you got 1 injection day 1, another day 2, and another day 3. So after 90 days for that individual the trial was complete for that person.

      The other trials were for additional rounds of injections. So I think in total you could get 9 injections.

      I may be off on my information. But thats what I remember.
       
    24. Hopeful1
      Depressed

      Hopeful1 Member Benefactor

      Tinnitus Since:
      04/2016
      Cause of Tinnitus:
      Loud Music
      That was in the past, now you only get 1 trial and 1 open label( 3 +3 )...
       

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