Otonomy Inc - Otividex

I WAS excited about this when they did the failed US trial. While I'm sure this method may be great/life changing for some, I'm closely related to someone who was in the trial. They know they received the medication, and it didn't do anything. :-\
Props for bringing up another potential treatment/news on it though, as we all like to stay abreast of the latest treatments and availability. If we all look long and hard enough, something will come around eventually, right?! ;D

 

I'm curious as to why they had good results in Europe but not the U.S. Here is the press release:

http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2315557

 

I wonder where in Europe. Lots of different standards there, depending on western bloc, eastern bloc, etc.

 

One month before my surgery ( September 2016) I got a phone call form an ENT form my hospital inviting me to take part in the trial of this new drug. I refused as steroid injections did not help me at all. However I do believe there are people who can benefit form this drug.

 

Mac,

Seems I offended you unintentionally, mostly because a)I was really only responding to the first part of what you wrote, as I did NOT read carefully enough and b)because I shouldn’t have tried to respond to your post so late at night! Bad move! For the record, I think being an activist regarding this disease is ALWAYS worthwhile. I support you. I support people trying any method they deem fit to fight this disease. Also, I only meant I wasn’t as excited as I was initially when it was explained to my family member. My supposedly good ear doesn’t seem to be doing well anymore. I’ll try steroid injections, and I’d try the experimental one too, before I’d have another surgical labyrinthectomy!

 

I'm agree with you Mac. Squeaky wheels get greased. No need to even cite the negative aspect of how some of the abhorrent personalities that bubble to the top in politics just because they are so darn squeaky. I sent Dr. Gotleib an old fashioned paper letter. I even lifted some of your language. Thanks for the suggestion.

I got steroid shots from Dr. Hammerschlag in NYC and after they made the vertigo worse for a while I seem to not get the crippling, horrible, nasty, stay in bed for 3 days kind of vertigo I used to. But my hearing got worse and stayed worse after the shots. It used to fluctuate. Now all I hear out of my bad ear if someone tries to talk to me from that side is Alvin and the chipmunks far off in the distance

I am now a big fan of the EDB (Endolymphatic Duct Blockage) surgery and trying to find someone in the NYC area who will do it. But absent that if Otividex was approved I'd give it a shot.

Thanks for your post.

 

Hi this is Hebe. I live in New York and had the EDB surgery in April 2016 (about 19 months ago).

Marta let me know that someone posted this: "I am now a big fan of the EDB (Endolymphatic Duct Blockage) surgery and trying to find someone in the NYC area who will do it."

I was in a very bad way prior to surgery. Have had Meniere's for about 10 years now and have had my share of terrible attacks. (I used to keep track of them, rating them 1-10 for how awful they were !!. Then they just got worse and more often so I gave up). Steroids worked for me over the years for the first 2 or 3 times, but then they were not helping at all and now I react really badly to them so no more for me.

Around March 2016 I was getting really bad. Nothing was working and I could get no relief. I was desperate. My doctor and I had talked often about options and I finally said I was ready for surgery. At that time the EDB version was quite new. The 3 versions I was given were decompression of the endolymphatic sac; a shunt; and now the clipping of the duct (EDB). I read what I could and, even though my doctor had never done this version before, I opted for it. The research showed good results and I was ready to jump in.

The Surgery was easy. I have been with Dr. George Alexiades (Weill Cornell) for many many years and he is a competent surgeon. Everything went well and I slowly regained my confidence and thought I was ready for life again. I don't know what happened or why, but this summer I started to get vertigo symptoms again. This was 14 months after my EDB surgery. I used to start with getting fullness in the ear and then the engines started roaring. Starting like a car engine and getting louder to a jet engine, I knew I was going to have an attack. Now, however, there was no fullness - the duct to the sac was clipped so there was no fluid buildup in the endolymphatic sac - makes sense - but the my other premonitions were accurate. I went to see Dr Alexiades and I went on steroids (a big mistake) and then it happened. In June (2017) I had a really bad attack (about 12 on my scale of 1-10 !!). I was so depressed and SO VERY disappointed.
I couldn't shake it either. Six weeks later I went to the doctor again and said I thought another attack was imminent. He thought not as it was 6 weeks from my big attack. But I was right and 4 days later it happened again (about a 5 on my scale this time, but it happened).

I am not saying that the EDB surgery was not successful, and it gave me huge relief at the time. But I do know it is not a complete cure.

I have been on hydrochlorothiazide (water pill) 25 mg daily since 2009 and was hoping to wean off this. After the 1 year of surgery I got down to 4 a week. I am now back to one a day and will be forever I expect.
In 2014 I started on Betahistine after some nasty attacks. I was on 3 a day (16mg) originally then was taking 2 a day through the years. After 1 year of surgery I went to one a day then stopped. I am now back on 2 a day and will stay that way for fear of more attacks.
Maybe I should have stayed on these drugs and not stopped them - maybe that was why I had attacks after surgery. I will not stop taking them again unless someone comes up with a really good alternative.
I read about cranial osteopathy and have now been trying that for a few months - not sure how much it is helping.

Maybe this is it for me. Staying stable and always staying aware of the monster that lurks.
Of course, I still have the tinnitus and the hearing in that ear is worse. I will look into getting a hearing aid at some stage.
For now I am back to day-to-day.

We all know that everyone's story is different. I hope this helps someone.
I am happy to share any more details that you want to know about the surgery or anything else.
Anyone is welcome to contact me directly at [email protected]

ALL THE BEST TO all of you out there whose life gets rocky sometimes.

 

Surgery and/or steroids can definitely work for some, but the only problem is that it does not treat the underlying cause, and it cannot stop someone from going bilateral. If, and i recognize this is a big if, the underlying cause is viral related, then surgery only treats the symptoms and not the root cause.

 

Okay, I’ll just plead dumb. Please spell it out for those of us who aren’t as quick as you?

1)EXACTLY WHO do you want letter addressed??
2)Address??
3)what content do you think should be in the letter?

So, maybe PM me??? I like things spelled out so I don’t screw them up.

 

AWESOME
Just didn’t know if we could do things like that in the forum, honestly, hence PM request.

 

Hebe
Thank you for sharing your experience with us. It should be helpful for those who are considering the surgery. She here is always pros and cons. I hope you find your remedy. Stay well!

 

Sorry Mac,
I only JUST read this. Haven’t been on much/not trusting myself to respond without enough O2 LOL

(I tend to be too cautious, but that’s because I can’t always remember all the rules without rereading)

 

Hey Mac,
I got this reply, to my letter, from the FDA. Thought you (and others) might be interested. It doesn't say much but its nice to know someone up there (over there) is saying the words "Meniere's Disease". BTW: Does anybody remember why we sometimes call Meniere's Disease "MM" and not always "MD"?


This is in response to your November 9, 2017, letter to Dr. Scott Gottlieb, Commissioner of the Food and Drug Administration (FDA), requesting the FDA to approve Otividex (OTO-104) for the treatment of Meniere’s disease as soon as possible. Your letter was forwarded to the Division of Drug Information in FDA’s Center for Drug Evaluation and Research (CDER) for a response.

Thank you for writing and expressing your concerns. We appreciate your desire to have new drugs approved as fast as possible to treat Meniere’s disease and are acutely aware the impact this disease has on a person’s quality of life. However, please understand that information about an investigational drug or an application under review is considered confidential and can only be disclosed to (or by) the drug sponsor as per regulations (see 21 CFR 312.130 and 21 CFR 314.430, respectively). These citations are federal regulations that do not allow us to release information for any product that is not approved by FDA.

FDA's mission is to ensure that products approved for human use are not only effective but safe. We recognize the importance of the development of novel and promising new therapies for diseases for which current treatment is unsatisfactory. Although the Agency cannot provide a definitive timeline for approval of these new therapies, FDA scientists are committed to continuing to work closely with all sponsors developing promising new therapies to help meet serious unmet medical needs.

Thank you, again, for writing.

Sincerely,

/s/
Donald Dobbs
Division of Drug Information
Office of Communications
Center for Drug Evaluation and Research
Food and Drug Administration