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
      Cause of Tinnitus:
      Multi-factorial
      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.
       
      • Informative Informative x 3
    3. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
      • Like Like x 2
    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.
       
      • Agree Agree x 2
    8. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      If their next trial (phase 3) goes well, the drug can be released to the public.
       
      • Like Like x 2
    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

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
      • Like Like x 2
    13. Pre55ure

      Pre55ure Member

      Location:
      California
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Vestibular Migraines? E. Hydrops?
      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/
       
      • Helpful Helpful x 2
    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.
       
      • Agree Agree x 5
      • Like Like x 1
    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...
       
      • Agree Agree x 1
    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.
       

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