New Menieres Drug study

I was in both of the trials.

 

I have never been told if I got the drug or the placebo. That being said...it was pretty obvious.

I was in the first trial in May of 2017. I am 99% sure I received the drug. It basically does what we all wished prednisone would do. It acts as a very strong anti-inflammatory for your inner ear. For whatever reason...the drug is able to make its way there. My hearing improved 15db. My fullness also went down considerably. I would say the drug is extremely helpful. Its not a cure...but it is a very good band aid.


My symptoms ramped back up in August 2016.

I was in the second trail in Oct-Nov 2016. I am 99% sure I received the placebo. My symptoms stayed the same. It was a miserable few months.

I have talked to Dr. Kil on the phone several times. Some of the results were amazing. I think like everything else...the earlier you try it - the more it helps. That is the good news.

The bad news - this is 6-8 years away from being approved.

That's as much our fault as it is the FDA. We make no collective noise as a group and that's why no one has ever heard of MM or have any clue what we deal with.

I would recommend reaching out the FDA and demand that this drug gets FAST TRACK designation. I would but I know the FDA is sick of hearing from me. Go gettem James! Good luck and feel well.

 

I’m pretty tired of the MM community’s lack of interest in pushing for effective treatment as well. A few absolutely amazing people have made serious effort. John of Ohio. Some of the members here. The Mind Over Meniere’s guy. Yet we all are dealing with the same thing and not one of us lives entirely without fear of this syndrome. And I’m forced to say syndrome because it isn’t even an identifiable set of diseases. I’m trying to create a diet and I may post it here for review/criticism/application (based on lysine-arginine ratio and hopefully antiviral ability). I would also be curious if one of the very helpful members would give me their opinion on mushroom supplements as they’ve been found (gypsy mushroom especially) to be particularly useful in combating viruses including HSV. We can collectively do something about our situations, but too many are idle in their ill-fate. Personally I refuse to give up without all of my fight. Apologies for derailing. This clinical trial _is_ good news for the future.

 

i'm hoping that this trial will do well.
http://www.otonomy.com/pipeline/otividex/

"OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone that has completed two Phase 3 clinical trials in patients with Ménière’s disease. We announced in November 2017 that the AVERTS-2 trial, conducted in Europe, achieved its primary endpoint (p value = 0.029) and that OTIVIDEX demonstrated clinically significant treatment benefit for patients. In August 2017, we announced negative results from the AVERTS-1 trial conducted in the United States. During the first quarter of 2018, we reviewed these results with the U.S. Food and Drug Administration (FDA). Based on FDA feedback, we believe that one additional pivotal trial is sufficient to support the U.S. registration of OTIVIDEX in Ménière’s disease, and we expect to initiate this trial in mid-2018."

 

We are a faux-orphan disease. 1/500-ish isn't that rare. With noise we should have overwhelming support. ALS is 1/100,000 and they literally cannot move, yet generated massive support.

 

Additionally, I've seen figures putting going bilateral as high as 50% arguing that the lower percentages have more to do with lack of long-term follow-up. This isn't an every-man problem, but it's certainly a-lot-of-men problem.

 

I still believe a prosthetic is our best shot. Drugs are going to continue to be a band-aid -- perhaps not antivirals, but other drugs -- till a cause can be determined. Prosthetics don't care about cause. In this way we are fortunate. I don't know how it could be done, but if someone were to create a replacement for the vestibular system that hooked up to the nerve, there's a solution that doesn't require knowing the pathology in its entirety. People have hand-prosthetics operating on similar mechanisms. Right now, sometimes my smartphone has a better sense of balance than I do.

 

A couple years ago I heard a story in NPR about the guy who sparked the idea for Otividex. He's a corporate pharma guy who had a vertigo attack while driving. After he was diagnosed he went to his team and they came up with the idea of the dextromethasone gel. Good to hear that it's coming along, although it's not really a breakthrough treatment IMO.

 

It is in the federal government's best interest in the US to fund this. Menieres is a disability and loads of people draw from SSI (currently I do not, but not my point). Probably somewhere close to 600,000 (I don't recall if this is occurrence or incidence, someone can do the proper math if they'd like). 600,000 x 12000. I don't know what that amounts to, but it's a lot of money yearly. I want a gyroscope telling my brain up and down so I can live my life without being crippled by a ridiculous ear disorder. And I know everyone here would like that, too.

 

We need to find our best option and line-up manifold behind a leading spear-head. We need to find the organization best equipped in spirit and academic might and direct awareness funding.

I do believe prosthetics will work before anything else. If nerve disease, then replace organic replicability with something inorganic and impossible to reproduce within. If trauma then replace the damaged component. This also allows us to recruit more groups behind us. Anyone suffering hypovestibular disorders. Not just us.

My vote stands with John Hopkins, but we need a line of communication. Maybe someone else can recommend another promising organization. We need to beat-down the doors of our government and explore funding there, too. Start a viral trend. Spin-around in circles and try some task and tag others to do it as well. Hammer that this is what it can feel like, but perpetually. Ask people empathize with our plight and join ranks. It can happen to them, God forbid. None of us saw it coming.

 

I think most importantly and most immediately, we need a stickied megathread so we can at least organize ourselves.

 

I am sure everyone has read that the phase 3 trials of Otividex failed and the company collapsed.

https://www.genengnews.com/gen-news-highlights/otonomy-suspends-otividex-development-after-phase-iii-failure/81254871

 

I learned every dragon guards a horde of gold. It's time to slay our dragon, take back our lives, and give a wealth to future generations. If we get a stickied thread, I would like that to be the title.

Slaying the Dragon.

I think it's a story we can all rally behind. I haven't met a larger threat on my life and I will not be idle in face of it. I cannot. There is one way forward. Driving steel through its black heart. Only you can let it take everything. The magic sword is embedded in stone because the stone is dormant. Anyone can pull it from the stone, but few do preferring to leave it dormant. There is nothing special about those that do, but their resolve to do so. Be a pity or be a warrior.

 

I had heard that Willheim, but wasn't sure if it was rumor.

 

I still think John Hopkins is our best bet, but I know little about them other than they're testing some kind of prosthetic. We need an open-line. If anyone has communication with them, let yourself be known. We need a funding direction.