SPI-1005 FDA fast track to stage 3 for Ménière’s disease , hearing loss and tinnitus

You mean this?
FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease

 

I had emailed the company a couple of weeks ago asking where they are at with this drug, and what the timeline might be to complete the trials. Never heard anything back. According to their website, it sounds like it's already in Phase 3 trials but no other information.

 

Glad to see something is being worked on. Wonder if this drug (if approved to roll out) helps existing Meniere's hearing damage or is more to help prevent damage to the newly diagnosed.

 

If I remember correctly the results of SP-1005 were dated for the first quarter of 2021. If there are no delays I would not expect anything before April.

 

That would be really great if there was anything that soon, although with this covid mess, I could see there being delays. It happens when it happens.

 

I think I remember reading that those in the trials did have some improvement in hearing but I could see that being really variable--depending on the severity of hearing loss and length of hearing loss.

There are other things being worked on to regenerate the hair cells and improve hearing.

I'd be happy to just not lose any more hearing and be rid of the other symptoms.

 

Maybe it will be delayed by Covid, but in June they started the current study, I think I posted the news at the time in the forum. What I mean is that there was already a pandemic when they started the new clinical trial, they could have stopped it at that point already and they didn't.

Anyway, the results will be published in 2021, but I don't know if after that it would be ready for commercialization or if more studies still need to be carried out.

 

Here is more info on this topic:

Has anyone tried to get Ebselen (SPI-1005) online?

Has anyone tried to get Ebselen (SPI-1005) online?

 

For hearing prevention and hearing loss reversing this could be a possible solution and you can use this already now.
Also there is connection with Menieres too, see all thread:

Dramatic Effect - Bone disease medications may reverse hearing loss

 

There is lots of info about dosing and which medications to take. This hearing loss and MD treatment is patented and available to everyone

Dramatic Effect - Bone disease medications may reverse hearing loss

 

I'm 69 years old. At the rate the FDA moves I'll be long gone before it becomes available.

 

I'm thinking the same about myself--I'm 67--at least as far as hair-cell regeneration thing. But the SPI-1005 does seem close enough that I could benefit.

 

See if transmastoid cochlear electrostimulation therapy is available in the US and information about it, you may be interested.

 

To try various drugs for MD you don't need FDA approval, good example is AVs

 

Treatment cost update sourcing Ebselen (also called SPI-1005) from China:

Has anyone tried to get Ebselen (SPI-1005) online?

Monthly treatment cost with the Ebselen now is similar to AVs.

There is still no FDA approval for treating MD with Ebselen nor with AVs, but a lot of us tried AVs and were having success, so why not to try Ebselen?

 

Thanks for the info. So far, all I've been able to find is that it's something being done in Spain. But I'll keep looking for whatever other info I can find.

 

I just found this - Phase 3:

Code:

Study Design

Study Type  :    Interventional  (Clinical Trial)
Estimated Enrollment  :    200 participants
Allocation:    Randomized
Intervention Model:    Parallel Assignment
Masking:    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:    Treatment
Official Title:    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
Estimated Study Start Date  :    May 2021
Estimated Primary Completion Date  :    May 2022
Estimated Study Completion Date  :    April 2023

SPI-1005 for the Treatment of Meniere's Disease - Full Text View - ClinicalTrials.gov

 

Has anybody tried to sign up for Phase 3 of this trial yet? Looks like it starts in May.

 

If anyone is part of these trials, I hope they will post their experiences. Hoping this will pan out and be approved. I've dealt with this misery for 50 years now and have never found anything that helps. Even if it didn't do anything for the hearing loss, I'd be happy just to be able to control the symptoms. No one should have to live with this.