I thought I'd add an update here since I'm now done the trial. Right now I'm feeling pretty good. I didn't see all of my audiogram results during my last and final visit, but I could tell that it was my best test of all the ones I did. The audiologist commented that I "got a lot more words right" in my bad ear than I have in the past. The clinic also commented that the drug has been helpful for the vast majority of their patients. So now we wait and see if it is approved. I started treating my TMJD 6 weeks ago and that could be the cause of the improvement as well. Since starting my TMJD program, I've barely had an ear fullness and I'm hearing better than I ever have in my good ear.
This is great news. I’m always glad to read that something is helping someone and hope you continue to do well. Thank you for reporting in on your experience for those of us following. What treatment are you doing for your TMJ? As a dental hygienist this piece of the Meniere’s puzzle has intrigued me. Are you wearing a night guard? Any occlusal adjustments? I am personally not sure if mine is TMJ related at all but I believe many can be. Ironically my issues started shortly after I had some significant dental work on the same side as my affected ear. Our bite and jaw joint can wreak havoc when they’re not in proper position. I hope you continue to get relief.
I posted in the thread here that is discussing the subject but I’ll share some here as well. I spent a full 5 hours during my assessment with an orthodontist that has devoted 30+ years to treating TMJ. They took the following images: Panograph - this is a 360 view that every dentist will do on a yearly basis. Tomogram - This is the main shot that showed the absence of a gap between the TMJ and my ear. Cephalograph - another source of imagery. They made a Gelb splint for me that I wear all day even while eating. I have a night time orthotic that covers my bottom teeth and a top one that has an extension protruding downward my bottom jaw to keep my jaw from dropping back and up into my ears. I’ve been a grinder for over a decade and used an NTI, which I’ve come to find out is the worse thing you can do if you have TMJD because it forced my lower jaw back and up. This is the exact Gelb I’m using. https://www.johnsdental.com/sleep-tmd/splints-nightguards/gelb/
Hello friends! I haven't been writing much on the forum because I don't have much to say, but almost every week I stop by to read you. Regarding SPI-1005, I guess there is no one left taking it because the study ended and now we just have to wait for the results to come out. In general, from what I have read both here and on other networks, it seems that it has given positive results for the majority of people. Let's hope they launch it on the market, although it is not 100% effective, it seems that it could help some people as happens with betahistine. I am especially interested in being able to try it myself to see if my hearing also improves (I have read that in some cases they improved up to 20dB). By the way, does anyone know who will distribute this medicine? I have tried to investigate SoundPharma, but they seem to only do drug research, not direct sales. Greetings!
That's correct, the study is done, now we wait for the results. I haven't heard anything about who will distribute it, but the trial clinic that I went to said they will keep every participant informed.
Official press release: SOUND PHARMA ANNOUNCES PHASE 3 STUDY COMPLETION OF SPI-1005 FOR THE TREATMENT OF MENIERE’S DISEASE
I did not get the opportunity to get a final exam at my trial clinic. The audiologist was gone and they did not have a replacement prior to my drug running out. One thing I will say in regards to improvement; it took many months, but towards the end I had quite a bit of improvement in the bad ear. It is fading now. Also, I have focal seizures. My new Epileptologist Neurologist put me on Gabapentin for the focal. This drug is known to help with Vestibular issues. He has a patient that has Menieres. He is on the drug and much better. Other than the light tinnitus and hearing issues, I would say I'm feeling about 90 % improved! Let's pray that SPI-1005 gets approved and on the market soon. Between that and the gabapentin I am praying I could see 95% improved. Take care and have a blessed day!
@Mark55 This is the first I've heard of using Gabapentin to help treat the symptoms. Very interesting. On my side, I feel pretty much the same as I did on the drug having been off of it for almost two months now with a few notably exceptions. I had a great July, I was hearing better than I have in at least a year, only to slip back this month. I also have almost no ear fullness. I started treating my TMJ disorder just under 3 months ago and this could be a positive result of that.
@MrE, I am quite confident that the drug did help the fullness in the bad ear as well as the hearing. It took a long time to see benefit, but hearing progressively improved. Every day off SPI-1005, my hearing gets a little worse and starting to feel some fullness. Not crazy full, but a bit more sensitive to sounds again. It makes sense as my doctor said once off the drug, I would start losing the ground I gained. Good luck with the TMJ treatment!
Could we explain the mechanism behind this a bit? Of course it makes sense that if you drop a maintenance drug, you'll lose its benefits, but I'm curious what's actually occurring between SPI-1005 and the inner ear when the drug is in use vs dropped.
I’m currently almost 7 weeks into taking Methotrexate, so if this doesn’t work for me, I guess SPI-1005 won’t work.
In regards to effectiveness of SPI-1005, it did help me. Especially now that I am off of it. I eat very healthy, but the last 2 days my tinnitus is through the roof. I bent over to get a snack for the pup and almost fell over. Dizzy and almost turned to vertigo. I never had this crazy ear fullness and insane tinnitus while on the drug. I can say it took a long time for the drug to improve my hearing. If it gets approved and you get on it, stay on it. Everyone is different and it took a long time for hearing improvement. Tinnitus sooner. Praying it gets approved sooner than later! Everyone should get the opportunity to give it a try. We shall see what the future brings! Take Care
I really hope this comes to market before I've gone completely deaf. It's almost criminal how long it takes for the FDA to approve stuff.
I believe the FDA has not yet received the results and petition to approve the drug. We are still waiting for the results of the final clinical trial to be announced.
When I was in the study my clinic rep told me that the drug company that was making it was being looked at for some ethics issues - not really sure what she meant.
That must mean it works. If they started 'looking at' pharmaceutical companies ethics, they'd all fry. This is usually what happens when a small company tries to make a cheap drug threatens a big company. Ebselen aka 'SPI-1005' solves a lot of other problems and could be used off label for about 20 other things. Google all the research being done for other maladies in conjunction with Ebselen. I was kind of afraid of this happening.