FDA petition

Ears, nose and throat
1

I hope everyone takes a minute to sign this. It is an FDA petition to get Otividex approved in the USA. Currently there are NO approved drugs in the US for Menieres. This would be the first!!

https://vestibular.org/civicrm/petition/sign?sid=6&reset=1

Sign up and pass it along!! 

2

Done, thank you. 

3

I signed and I hope this is a legitimate treatment. We need relief, not people trying to make money off of Meniere’s suffers. 

4

You're so right Jim.

5

DONE....thanks for bringing this to our attention.  VEDA is a most reputable and legitimate non profit focusing on Vestibular disorders.  Otividex is legit.  It is a long lasting dexamethasone (steroid) that can be used to reduce inflammation/fluid buildup in inner ear.  Unfortunately test results in USA have not proven its effectiveness in its current formulation and protocol.  That should be rectified with further testing and reformulation.  Anticipated results are encouraging.

6

Done!

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Hi Bmac,

Thanks so much for the info.

ENT’s have been using intratympanic Dexamethasone in the U.S. to treat Meniere’s associated vertigo for at least a few years....Otividex is simply a “stickier” version of the stuff, the idea being that it would adhere to the structures of inner ear longer than regular Dexamethasone, which basically gives the inner ear a quick bath.  

I was discussing this  with my Otolaryngologist a couple of weeks ago while I was getting my injection, and while he had great hopes that Otividex would  bring quicker and perhaps more lasting improvement over the current treamtment with regular Dexamethasone, he was disappointed that Phase 1 Clinical trials in the U.S. just didn’t show that it worked any more effectively than regular Dexamethasone.

My experience with the intraocular Dex injections has been that they’re very effective  when given every 4 weeks until symptoms begin to decrease in frequency and intensity, and then you can begin to stretch out the intervals between injections, according to how you’re feeling.   Interestingly, with me, there seemed to be a bonus cumulative effect with the injections:  In addition to the radical reduction in vertigo, I have also experienced a decrease in tinnitus and an improvement in my hearing. 

I hope this new drug is reformulated so that it will eventually do what they hoped it would do, but there’s no reason to wait  to see if intraocular steroid injections might help you.  They’re available now from ENTs and Otolaryngologists who are trained in the procedure. 

Wishing the best to everyone.....

J-

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Signed it!

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Re: my post, above.....I have NO idea why I typed “ intraocular” when I meant “ intratympanic”!!!  Sorry about that!  Not having my best day! 

Take good care, everyone!!!

J-

10

Thanks everyone for signing!!

We are close to 1000 signatures. I know this is NOT a cure but if it helps one person then it should be approved. 

Just do you know... I am not associated with Otonomy in any way. Or VEDA. I reached out to VEDA with this idea and they got on board. 

Feel free to forward the link to family and fiends. Put your story in the comments!!

Feel better!