Good news for Ménière sufferers:
https://www.biospace.com/article/re...i-1005-in-the-treatment-of-meniere-s-disease/
With a fast track, how long do we think it'll take before this drug hits the market, if all goes well?
Good news for Ménière sufferers:
https://www.biospace.com/article/re...i-1005-in-the-treatment-of-meniere-s-disease/
With a fast track, how long do we think it'll take before this drug hits the market, if all goes well?
Your guess is as good as mine.So how many more trials do they need?
This is really exciting news for Meniere's sufferers, but also possibly for people with newly onset acute tinnitus and hearing loss. It may potentially be able to short circuit some of the damage that most of us now have to live with.
Most heartening however, for future possible hearing loss drugs, is that the FDA is willing to grant Fast Track Status for otological medicines.
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!
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.
Your guess is as good as mine.
It seems like it might but it is not clear if it applies to chronic cases, too.This is only for people with Meniere's? If it helps reduce tinnitus, shouldn't it help us with noise induced tinnitus?
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.It seems like it might but it is not clear if it applies to chronic cases, too.
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):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.
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.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
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.
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.To administer this emergency treatment for people who have suffered an unforeseeable and irresistible acoustic trauma: exploding tire, airbags...
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."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?
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:"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?
Age-related is never acute so I came to the same conclusion.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 ?
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.
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.
If they don't have a statement precluding expanded access, you could apply with your doctor. Who knows, they could grant it.But why wait? I can't find anywhere if they are open for expanded access.