Sound Pharmaceuticals (SPI-5557 & SPI-1005)

Discussion in 'Research News' started by joe, Jan 26, 2012.

    1. Stefaniie

      Stefaniie Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      noise exposure
      • Good Question Good Question x 2
    2. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      From what I read, a fast track shortens time of review post phase 3 from 10 months to 6 months and starts the review process before all parts of application are complete. So, soon after phase 3 is complete, it sounds like to me.
       
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    3. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      I can't edit my previous post but i meant, on average. There is no set in stone review time, it's all case by case.
       
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    4. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      Your guess is as good as mine.
       
    5. Chriscom

      Chriscom Member Podcast Patron Benefactor

      Location:
      Northern Virginia USA
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Likely infection/ear stress after walking pneumonia
      Interesting indeed. But I'm confused about something. Is the hearing loss associated with Meniere's different than than, I don't know how to put this, many other folks? I have sudden sensorineural hearing loss and tinnitus, and reading the press release, I don't see any mention of hair cells. I don't have Meniere's, apparently (multiple ENTs and such seem to agree) but the PR's mention of restoring hearing and reducing tinnitus obviously caught my attention. With an oral dose no less!
       
    6. Chriscom

      Chriscom Member Podcast Patron Benefactor

      Location:
      Northern Virginia USA
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Likely infection/ear stress after walking pneumonia
      Going to add a clarification to this: I don't have the vertigo usually associated with Meniere's, though on occasion I've seen reference to "atypical Meniere's" without it. Nevertheless my team, including a super-duper research/cutting-edge ENT, concluded I don't have Meniere's. So I'm curious if this drug, if it pans out, is potentially another path to a cure or improvement for me.
       
    7. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      This drug is an anti-inflammatory medicine and mitigates swelling in the inner ear, which is believed to cause Meniere's Disease symptoms, such as vertigo, fluctuating hearing loss and tinnitus.

      They also believe it can prevent inner ear damage becoming permanent due to noise, SSHL, or ototoxicity in the acute stage. It won't restore dead hair cells.
       
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    8. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
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      Multi-factorial
      If their next trial (phase 3) goes well, the drug can be released to the public.
       
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    9. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      these drugs are for acute cases though right?
       
      • Agree Agree x 2
    10. Momme

      Momme Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Loud noise?
      This is only for people with Meniere's? If it helps reduce tinnitus, shouldn't it help us with noise induced tinnitus?
       
    11. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      It seems like it might but it is not clear if it applies to chronic cases, too.
       
    12. Momme

      Momme Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Loud noise?
      Let's hope for the best. Still got a lot of hope for Susan Shore because she told me it's for us with noise induced tinnitus.
       
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    13. Pre55ure

      Pre55ure Member

      Location:
      California
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Cochlear migraines
      Is there anyone following the release of this drug that could direct me to any resources that can explain the physical process by which E. hydrops / menieres causes low frequency hearing loss?

      I have found quite a bit of literature available explaining inner hair cells, outer hair cells, synaptopathy, etc... and how these relate to age related or noise induced hearing loss, but despite a lot of searching - almost nothing related to E hydrops related hearing loss.
       
    14. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Per this paper, there are a ton of effects starting from early (OHC) to intermediate (fibroblasts) to late (Spiral ganglion neurons-though i would be careful correlating animal studies here since their spiral ganglion neurons are different):

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923478/
       
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    15. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      So to sum up and resume, regarding NIHL (not Meniere), Sound Pharmaceuticals:

      - did a phase 2 clinical trial with SPI-1005 for Prevention of Temporary Auditory Threshold Shift with healthy subjects
      https://clinicaltrials.gov/ct2/show/NCT01444846
      and the results were good (see attached file),

      - are currently leading a phase 2b clinical trial with SPI-1005 to Prevent Acute Noise Induced Hearing Loss with Subjects with a History of either recreational and/or occupational exposure to noise and volunteering to be exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
      https://clinicaltrials.gov/ct2/show/NCT02779192
       

      Attached Files:

    16. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      I'm sorry, but who gives a fuck about a drug to prevent NIHL? They're called ear plugs. Give me a drug that treats this madness.
       
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    17. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      To administer this emergency treatment for people who have suffered an unforeseeable and irresistible acoustic trauma: exploding tire, airbags...
       
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    18. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      I see. I'm clearly no scientist, but if they know how to prevent it with a mechanism, then they'd probably know how to identify it and combat it for current sufferers like myself I would think.

      Let's just hope a cure is on the way.
       
    19. ThomasRobert

      ThomasRobert Member Benefactor

      Location:
      ME
      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Ototoxic
      Sound Pharma advances pivotal Phase 3 clinical trials in Meniere's Disease

      Sound Pharmaceuticals is pleased to announce that the FDA has allowed its pivotal Phase 3 clinical protocol for SPI-1005 in the Treatment of Patients with Meniere's Disease (STOPMD-3). This is the first Phase 3 study of an investigational new drug for the treatment of Meniere's Disease (MD), a neurotologic disease involving hearing loss, tinnitus, and dizziness.

      ..... Additionally, SPI-1005 treatment reduced tinnitus perception or tinnitus loudness (TL) by a statistically significant difference (p-value <0.05 using Fisher's Exact test) when compared to placebo. Reductions in TL averaged 1.4 pts in the 400 mg group vs 0.7 pts in the placebo group (30% reduction vs 10% reduction, p<0.02). These Phase 2b data confirmed an initial finding of the Phase 1b data, that SPI-1005 can reduce tinnitus loudness by clinically relevant levels. These improvements in auditory function further support the use of SPI-1005 to treat sudden hearing loss, noise-induced hearing loss, and age-related loss where sensorineural hearing loss and tinnitus are prominent features.


      Link:
      https://www.dailyrecordnews.com/new...cle_8b3f0f38-66f6-5b82-85f3-0904c7164343.html
       
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    20. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
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      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      "These improvements in auditory function further support the use of SPI-1005 to treat sudden hearing loss, noise-induced hearing loss, and age-related loss where sensorineural hearing loss and tinnitus are prominent features."

      So is this only for Meniere's disease related tinnitus? Or can this be used for any kind of tinnitus? I'm not informed about this drug and the pharma behind it? Because in other post I read about acute stages only or perhaps only affecting lower frequencies?
       
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    21. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      The trial is for Meniere's but it appears useful for treating the inflammatory component of many etiologies. So might be a good drug to try off label especially since it seems safe.
       
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    22. Emgee

      Emgee Member Podcast Patron Benefactor

      Location:
      United States
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      03/2020
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      Modern Society = Too Loud
      Not sure if this drug can help non-Meniere’s sufferers also, but Sound Pharmaceuticals does have treatments in the pipeline for hearing loss and tinnitus. Per my discussion with CEO and Chief Medical Officer, Jonathan Kil:

      “Yes we have four active INDs in hearing loss and tinnitus indication. In addition, we are measuring hearing function in the non-Meniere's ear especially at higher frequencies”
       
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    23. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      So let me use my brain. It says:
      -sudden hearing loss
      -noise-induced hearing loss
      -age-related loss where sensorineural hearing loss and tinnitus are prominent features

      So this would mean that it's not only for acute stages :angelic:?
       
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    24. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Age-related is never acute so I came to the same conclusion.
       
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    25. Croaker
      Haunting

      Croaker Member

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Unknown
      “SPI-1005 is given orally and is being tested in several neurotologic indications including noise induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness or vertigo): due to aminoglycoside antibiotics (such as tobramycin) and due to platinum-based chemotherapy.“

      It’s some sort of anti-inflammatory drug that’s replacing a molecule that they have figured out is depeleted in a damaged inner ear. Sounds like it could work for everybody. Exciting to see.
       
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    26. HootOwl

      HootOwl Member Podcast Patron Benefactor Advocate

      Location:
      California
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      Cause of Tinnitus:
      Explanation in About You
      Oh wow, this sounds like it could work if your hearing issues are due to underlying cochlear inflammation, and could also tide us over until the Hough pill comes along.

      My reactive tinnitus/hyperacusis could very well have an inflammatory component so I’ll definitely be keeping a very close eye on this until it releases.
       
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    27. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      I was thinking that as well, but I can't find anything about the possible side-effects. I (or anyone in that matter) don't want to ruin any changes for FX-322. If it depletes supportings cells like you mentioned audion's drug did then it's better to wait.

      I saw this statement "No serious adverse events occurred, and the majority of adverse events were mild to moderate, and consistent with those observed in prior studies." But have no clue what the adverse advents are.

      https://soundpharma.com/soundpharma...005-phase-2b-menieres-disease-clinical-trial/
       
    28. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      But why wait? I can't find anywhere if they are open for expanded access.
       
    29. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      If they don't have a statement precluding expanded access, you could apply with your doctor. Who knows, they could grant it.

      But it may be worth contacting the company to see what their policy is.
       
      • Agree Agree x 1
    30. Pre55ure

      Pre55ure Member

      Location:
      California
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Cochlear migraines
      I think I'm (personally) more excited about this than I am FX-322. I'd love to see if I can get in to that 3rd phase trial.


      (Totally unrelated question, is there a way to direct message other members on here? If so could someone DM me and tell me how to do it. Thanks!)
       

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