For those of you having a crappy day...read this: Sound Pharmaceuticals announces positive topline results from the SPI-1005 Phase 2b Meniere's Disease clinical trial I was in Phase 1 and Phase 2. Happy to answer any questions. Keep your chins up folks... they are getting there!! Mac
This is very good news. What are the next steps for this? Do they do another trial with even more participants?
It at least gives us all some hope that work is finally being done to find something that might help us.
Hi Mac. Great news indeed! Did your symptoms all return after you completed Phase I? Or did you have sustained improvement? Also, did you get improvement in all areas ie. lower tinnitus, less aural fullness, less vertigo and improved hearing or just some of these? Thanks.
Zotjen, Personally... I think the focus should be - how do we put the full court press on the FDA to get this approved asap? This is not a cure. I know...I took it. It works like a Excedrin does for your headache. It works while you take it. It helps with symptoms. It helps a lot to be honest... But it will not stop future headaches. My point is... even if you get in the trial you will still suffer from MM. It will only help you while you are on it (if you don't get the placebo) and your underlying symptoms will return weeks or months later. That is why it is important that we coordinate together as a group and get this product approved asap so that it is on the shelf every time you need it...make sense? So how do we do that? We immediately start bombarding the FDA with letters and petitions to get this drug fast tracked through Phase 3. Tell them your story...How this disease has affected you and your family. I have written many letters to the FDA. They get your letter. They read it. They even write back to you. I will get mine out this weekend. We have to pressure them. Otherwise they will continue to care less about us and our disease most people have never heard of. Hope everyone has a great day. mac
Mac, At the end of the trial they told you what you were getting, placebo vs. real drug? Thanks for the info. Jim
It appears this new drug addresses hearing loss. I see nothing about the other Menieres symptoms like vertigo
Dnprn, Here is the address. In the past I have asked close family members and friends to write as well. Go get them! Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 attn// Norman E. “Ned” Sharpless, M.D (acting commissioner) Jim, They didn't need to tell me. I was 100 percent on it for phase 1 and I definitely got the Placebo in Phase 2. Hope that helps. Mac
Mac, thank you for posting the address. I will write that letter and get it in the mail within the next few days. Which of your symptoms did the drug improve?
I posted this information on another Meniere's support board I visit occasionally, along with a link to this site so whoever sees my post can read about it here, also referred them to the Soundex site so they can read about it there. That board doesn't get much action but even if a few people see my post and choose to write the FDA, it will help the cause. Just a thought...I am not on any social media sites but is there any way that those who are can get the word out that way? We need to reach as many people as we can.
Cal. Sun, I posted the information on my facebook page. Both the info about The Hough Institute and Soundex. Yes, I agree as many people we can get to become aware of this awful disease and other ear issues.
The FDA site on fast-tracking says "Fast Track designation must be requested by the drug company." @Mac do you know whether Sound Pharmaceuticals has requested this? Should folks reach out to them as well?
Focus on the FDA. Sound Pharma is run by a smart crew...They will be shooting for fast track without any help from us. They know the deal with orphan diseases. Thanks for your help Bob - every letter to the FDA will helps our cause!!
Hearing-loss drugmaker Sound Pharmaceuticals posts strong clinical results, eyes an IPO My boy Dr. Kil is making it happen!!! Now it's our turn. There is an old quote I think applies to this situation... "Action is the antidote to despair" We can sit back and wait for things to happen in our lives or we can kick down the damn door and make it happen. We need to let the FDA know that we are out here and we need these drugs approved. Take some time this week to write a letter to the FDA and tell them your story. Every letter helps folks!! Have a great day. Mac
Excellent News Mac! I hope they make a big success of their IPO (i may even try and buy a few shares). Their Company has the potential to help a huge amount of people so i hope they are successful. Thanks for the update.