Sound Pharmaceuticals (SPI-5557 & SPI-1005)

Most of us here have lost our lives because of this damn disease. We need HOPE at least for our mental health.
I have hope. Read my thoughts on the middle ear implants and, to a lesser extent, Auricle. I have hope because there is some evidence they could be effective.

I can't just walk around in blissful ignorance, hoping.

I would also like Derby County to win the FA Cup next year. I'm not very hopeful, though.
 
With all respect, personally, and even though your opinion might be rational, I think we should stop spreading negativity on Tinnitus Talk.

Even the sponsor of this drug (if I understood it correctly) said that it might help noise-induced tinnitus. So maybe it will work for chronic noise-induced tinnitus as well; we don't know. Let us hope.

Most of us here have lost our lives because of this damn disease. We need HOPE at least for our mental health.
I think @Nick47 is one of the least pessimistic or negative people on Tinnitus Talk. He probably posts the most research-related materials compared to other users on this board. He is very hopeful that something will be figured out. I think he tries to stay cautious and rational regarding different treatments.

Now, for me, I like it when anything is tried for tinnitus. At least when something is tried, we will know whether it works. I honestly would not be surprised if a treatment is found that people were initially doubtful about.
 
I think @Nick47 is one of the least pessimistic or negative people on Tinnitus Talk. He probably posts the most research-related materials compared to other users on this board. He is very hopeful that something will be figured out. I think he tries to stay cautious and rational regarding different treatments.

Now, for me, I like it when anything is tried for tinnitus. At least when something is tried, we will know whether it works. I honestly would not be surprised if a treatment is found that people were initially doubtful about.
You're spot on, Gumbo. Research and experiments are inherently optimistic, simply by existing and being put into action. What really excites me is when concepts evolve or expand in some way. For example, the discovery paper on hidden hearing loss and its influence, or Susan Shore's shifting focus to the brain rather than just the inner ear. That's not to discount the research on the inner ear—after all, it could involve both the brain and the inner ear for all we know.
 
Sound Pharma announces positive Phase 3 results for the treatment of Meniere's disease with SPI-1005
SEATTLE — Sound Pharmaceuticals is pleased to announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Meniere's Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination.

Meniere's disease (MD) is an inner ear disorder that involves fluctuating hearing loss and tinnitus, and episodic vertigo and/or dizziness. There are no FDA-approved medical treatments for MD, nor for the treatment of hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple hearing loss and tinnitus indications including MD.

STOPMD-3 enrolled adult subjects (N=221) with a history of definite MD and active symptoms into a randomized double-blind placebo-controlled trial (RCT) in which subjects received 28 days of either SPI-1005 (400 mg twice daily) or placebo treatment with monthly follow-up assessments of auditory and vestibular function through 84 days. Compliant patients could immediately enter an open label extension (OLE) of SPI-1005 treatment for up to 12 months. During OLE, subjects continued to receive SPI-1005 and had their auditory and vestibular function reassessed every 3 months. In both the intent-to-treat and per-protocol RCT analysis, the SPI-1005 group showed higher rates of improvement in low frequency hearing loss (≥10 dB gain at one low frequency from baseline) using pure-tone audiometry (LFPTA) and speech discrimination (≥4-word increase from baseline) using the words-in-noise (WIN) test than the placebo group at day 28, 56, and 84 of follow-up. On day 84, the SPI-1005 group showed a significant rate of LFPTA improvement over placebo (57.9% vs 36.5%, an increase of 58.6% over placebo, p-value=0.0037). When LFPTA criteria were increased to require a ≥10 dB gain at two adjacent low frequencies from baseline, the SPI-1005 group showed a significant rate of improvement of 204.4% over placebo (41.1% vs 13.5%, p-value <0.0001). On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336).

During OLE, responder rates involving LFPTA and WIN continued to improve, and patient reported outcome measures for tinnitus, vertigo, aural fullness, and dizziness severity all improved significantly from baseline (≥30% on average, p-value <0.001).

"We would like to thank all of our investigators and study participants for contributing to this pivotal Phase 3 trial success involving SPI-1005," said Dr. Jonathan Kil, MD, CEO of Sound Pharmaceuticals. A presentation of the full RCT/OLE data analysis as well as additional post-hoc analysis will occur at the Association for Research in Otolaryngology Midwinter Meeting in Orlando FL, February 22-26.
 
Duh... Please correct me if I am wrong here. I would love to be proven wrong, but Menière's (pardon my French) has to do with the organ of balance, which is located right next to the cochlea.

That said, I might still benefit from the success of the trial, as my sense of balance is not the greatest. And who knows? It might even help lower my tinnitus by a decibel or two.
 
That said, I might still benefit from the success of the trial, as my sense of balance is not the greatest. And who knows? It might even help lower my tinnitus by a decibel or two.
I hope it does. I think they are doing a noise-induced tinnitus trial, but I would be very surprised if it was successful. I don't want to raise false hopes; there are many more promising things in the pipeline.
 
I disagree. Of course, you need to keep a rational, grounded outlook. None of us here will be cured in the next 5 years, but every step gets us closer to our destination.
What you say has a grain of truth. Progress, growth, change, decay, or even learning a subject or a language can occur gradually and incrementally. However, it often happens in spurts as well.

This medication is not the first one to lower tinnitus. We have Lidocaine (which can only be used short term) and, what is it called? Retigabine or something similar? Unfortunately, the side effects of these treatments are too severe to make them practical options.

If Sound Pharmaceuticals' treatment shows even slight effectiveness, who knows? It might encourage Big Pharma or major biopharma companies to get involved.
 
I hope it does. I think they are doing a noise-induced tinnitus trial, but I would be very surprised if it was successful. I don't want to raise false hopes; there are many more promising things in the pipeline.
What would you say is the most promising option in the pipeline at the moment?
 
Not this.

Take a closer look at middle ear implants or perhaps Neurosoft. Auricle might also provide some benefits.

Ultimately, it may depend on Tinnitus Quest and how much funding can be raised for human research to explore other options. Every dollar counts!
 

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