Otonomy OTO-313 — Treatment of Tinnitus

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      No way! That’s good news man.
       
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    2. anton40

      anton40 Member

      Tinnitus Since:
      05/2021
      Cause of Tinnitus:
      unknown
      Mine is indeed caused by TMJ. I got a couple of punches on my head for actually no reason at all. On my audiogram there was no visible hearing loss, so that's why I know for sure that it settles in the brain. But there are more than 200 causes of tinnitus.

      I hope OTO-313 will also solve tinnitus for people without any hearing loss.
       
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    3. Christiaan
      Inspired

      Christiaan Member Podcast Patron Benefactor Hall of Fame

      Location:
      The Hague, the Netherlands
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      2016: headphones, 2020: worsened thanks to Rammstein
      Thank you for letting us know @Sentinel. It's great that you're getting better and I hope that this effect sustains. Enjoy your life in (relative) silence!
       
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    4. AmePerdue

      AmePerdue Member Benefactor

      Location:
      France
      Tinnitus Since:
      May 10, 2021
      Cause of Tinnitus:
      Unknown - Likely ear infection
      I'm really hoping this can work for long-term tinnitus. I'm 3 months in and the idea that the window of opportunity is going to slowly pass and be gone by the time the drug is commercialized is terribly sad. Gives me a feeling of powerlessness.
       
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    5. Massi91

      Massi91 Member

      Location:
      Hannover, Germany
      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Perforated eardrum and prob. Noise Trauma
      My guess is if it works for those who have had tinnitus for 3-4 months, it will work for chronic cases too, because I have witnessed many people after 4-5 years just healing spontaneously or by changing diets, so I think it´s bullshit that it´s stuck in the brain.

      When someone habituates, the brain should fix itself after a while but it doesn´t, which shows that there is a cause and once that is removed, the tinnitus will go away too.
       
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    6. anton40

      anton40 Member

      Tinnitus Since:
      05/2021
      Cause of Tinnitus:
      unknown
      Yes but for those people (and that aren't just a few) who don't have hearing loss but do have a unlivable tinnitus, just a cure for tinnitus would mean the world for them.

      For me it would mean that I can regain my life, which I lost on a very stupid way.

      Personally I think that if the only problem you have is that you can't go to festivals anymore you don't have a problem at all, I mean after all you could miss festivals, right? For me it means that not only can't I go to festivals anymore, but my life has also become unbearable and I can't do anything anymore. I really have to say that if there was a cure which meant that I would lose my hearing but also lose my tinnitus, I would take it without any kind of hesitation.

      Additionally, I guess for people who have hearing loss, only solving the tinnitus will already make a world of difference.
       
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    7. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      As well as that whole issue with somatic tinnitus. If it is just stuck in the brain, then why does the sound significantly change when I move my jaw or pull back on my scalp. Seems like there is some sort of continued input going on.
       
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    8. Mica Rambin

      Mica Rambin Member

      Tinnitus Since:
      09/2020
      Cause of Tinnitus:
      NIHL
      I agree. I can manipulate the volume of my tinnitus by clenching my jaw… and when it starts to rise in volume, for some reason staying hydrated helps a little bit. I think that tinnitus is linked to some kind of nerve damage that can be fixed and theoretically quieten tinnitus.
       
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    9. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      #Absolutely, I could live with some hearing loss as hearing aids will help, but my tinnitus is like yours, it is severely affecting my life.
       
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    10. MRItechssuck
      Disappointed

      MRItechssuck Member

      Location:
      USA
      Tinnitus Since:
      Severe 10/17/2019
      Cause of Tinnitus:
      Loud noise, MRI
      I could have just made the earlier study, but at the time no one on the forum thought much of OTO-313, so I took a pass... shame.

      Now... I am outside the window since I am at 20+ months. Like some... I got this through no fault of my own, other than trusting a medical “professional.”
       
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    11. Exit

      Exit Member Benefactor

      Tinnitus Since:
      01/2020
      Cause of Tinnitus:
      Noise
      @Sentinel :)

      Some desperate people here are dying to hear how’s it going :)

      Still the lowest tinnitus you ever have experienced since you got it half a year ago?

      Hope you’re doing well :)
       
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    12. Ehren M
      Nerdy

      Ehren M Member

      Location:
      USA
      Tinnitus Since:
      01/24/2021
      Cause of Tinnitus:
      acoustic trauma
      Well, there was only a 50% chance of you actually receiving the drug rather than the placebo, so it's not necessarily a loss (except in terms of the potential to add another datum to the study).
       
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    13. canteven

      canteven Member

      Tinnitus Since:
      03/01/2021
      Cause of Tinnitus:
      Noise
      Me too. Let us know @Sentinel how it’s going :)
       
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    14. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      05/2019
      Cause of Tinnitus:
      Autoimmune hyperacusis from Sjogren's Syndrome
      Dear everyone:

      I know your intentions are not bad, but please consider that a drug succeeds only if the treatment group beats the placebo group by a large amount.

      In other words, everyone joining the trial with "optimism" is NOT a good thing for a clinical trial. Please, please, please stop documenting this stuff. Both FX-322 and OTIVIDEX (failed two Phase 3 trials!) were impacted by placebo belief.
       
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    15. Sentinel
      No Mood

      Sentinel Member

      Tinnitus Since:
      Late November/Early December 2020
      Cause of Tinnitus:
      Really epic hobbies
      Still got that low tinnitus! I'm actually at the clinic right now waiting on my hearing test before I go home. I spoke with the nurse who does all my visits and she told me that out of the 4 people dosed at the clinic so far, me and one other have experienced improvement, which I guess isn't bad as far as the odds go.

      Also slightly unrelated note, this clinic is currently enrolling for the OTO-413 trial which I found interesting. I was talking to the nurse about tinnitus and Otonomy and it came up. I don't fit the trial criteria but it's nice to know.

      Good to see things progressing.

      EDIT:

      I just was in the sound proof room they use for testing and all I could hear was faint static.
       
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    16. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      05/2019
      Cause of Tinnitus:
      Autoimmune hyperacusis from Sjogren's Syndrome
      @Sentinel:

      You seem like a really sweet and kind person. Your intentions are wonderful and you have a heart of gold. Very kindly, I want to try to explain why I disagree with you chronicling your experiences.

      The main primary end point in this trial is TFI. If you look through the TFI test, many of the questions are based on distress/QoL/outlook. I did the math and for someone to become a "responder," (a TFI reduction of at least 13 points), they basically need to improve by 20% in these highly subjective areas.

      Let's say a placebo patient "spots" something in this thread from your chronicling. They could easily become a responder. While this isn't your fault, hearing metrics are very primitive so all of the standards fall back on antiquated tests like TFI, which are not that scientific or hearing based.

      There's a historical precedence of "placebo performances" hurting trials. In fact, Otonomy's own Meniere's drug, OTIVIDEX, made its way all the way to Phase 3. It ended up failing two trials because of strong placebo performances. Actually, the drug worked for the people who followed the protocol.

      I can't emphasize enough how much these companies are up against the wall. The "hope" is just not worth it. Remember all of the "hope" we all had before FX-322 Phase 2? Yeah, it came crashing down. It is far more important for drugs to demonstrate a strong stratification between the placebo and treatment group.

      The nurse telling you these things is highly irresponsible. Trust me, hope does not help clinical trials succeed.

      With this said, you are a sufferer and I really hope you find relief. You seem like a good dude.
       
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    17. Exit

      Exit Member Benefactor

      Tinnitus Since:
      01/2020
      Cause of Tinnitus:
      Noise
      Thank you so much for an update. Very happy for you! For many here this brings a little hope back. If they get this to market, it will be a much needed cash flow and keeps the other companies on their toes :)

      Have a great day!
       
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    18. Kenilworth

      Kenilworth Member

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      unknown
      Thank you for the update. I'm rooting for you!
       
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    19. Sentinel
      No Mood

      Sentinel Member

      Tinnitus Since:
      Late November/Early December 2020
      Cause of Tinnitus:
      Really epic hobbies
      Thanks for posting Exit. It means the world to me. I am very hopeful for the future.
       
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    20. Gee82

      Gee82 Member

      Tinnitus Since:
      12/2018
      Cause of Tinnitus:
      Noise
      Awsome news! Maybe the other two that didn’t improve were given placebo, who knows.
       
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    21. canteven

      canteven Member

      Tinnitus Since:
      03/01/2021
      Cause of Tinnitus:
      Noise
      That’s wonderful @Sentinel!

      When will you have the results of your hearing test?
       
    22. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      So the hype builds... again.

      Can't get an erection just yet.

      I'm so used to tinnitus research failures that it's part of my life now.

      Wish them the best of luck though and all the riches in the world if they've cracked at least part of the puzzle.
       
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    23. Sentinel
      No Mood

      Sentinel Member

      Tinnitus Since:
      Late November/Early December 2020
      Cause of Tinnitus:
      Really epic hobbies
      It's just a routine test, my hearing is fine. They only tell me about the results if there is something anomalous.
       
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    24. Ali.sy

      Ali.sy Member

      Location:
      Deutschland
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      Headphones
      We need another superhero who has had the injection and wants to post about their experience.
       
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    25. Paul Walter

      Paul Walter Member

      Tinnitus Since:
      09/2000
      Cause of Tinnitus:
      Industrial noise
      Overall I think this is positive, we can only hope.
       
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    26. Exit

      Exit Member Benefactor

      Tinnitus Since:
      01/2020
      Cause of Tinnitus:
      Noise
      I can do a round of OTO-6XX :)
       
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    27. JRC1

      JRC1 Member Benefactor

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      medication
      @Sentinel, thank you for your posts. They are encouraging.

      Did the trial administrator just ask you how long you have had tinnitus?
       
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    28. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Thanks for the updates @Sentinel. So glad OTO-313 appears to be working.

      Anyone have an approximate release date assuming everything goes smoothly?

      Any FDA fast track going on with this?
       
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    29. Cernuto
      Spaced

      Cernuto Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise Induced
      FDA Phase 2 is expected to end August 2022. Phase 3 will likely start months after that and take over a year to complete. Maybe late 2024?
       
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    30. Sentinel
      No Mood

      Sentinel Member

      Tinnitus Since:
      Late November/Early December 2020
      Cause of Tinnitus:
      Really epic hobbies
      Yes, they did. They took anyone into that trial that had it less than a year.
       
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