[Vance]

I started taking Relyvrio (AMX0035) as a participant in the clinical trial since March 2018.  I have not experienced any of the side effects that are listed for the drug.  Yes it has an extremely strong taste.  I have found that letting it sit in lukewarm water for around 30 minutes gets it to dissolve more thoroughly.  I usually take it prior to breakfast and dinner.  A bit of peanut butter, for me, helps to get the taste out of my mouth as well.  I am on Radicava Oral, as well as riluzol.  At my last ALS clinic my neurologist said there has been no change in my condition or decrease in my ALSFRS in the last 3 years.

The VA has just established the criteria for prescribing Relyvrio and, as I understand, will fill prescriptions it at no charge to qualified vets that are in VA Health.

 

[Vance]

I have been a participant in the clinical trail  of AMX 0035 since 2018.  Below is the public testimony I gave to the FDA at the hearing.  My response to AMX0035 may not be typical, however I believe there were other case similar to mine.  

I was diagnosed with ALS in December 2017. I have been a participant in the Centar Clinical Trial since March 2018.

At the time of my diagnosis in the 2017 I was experiencing great weakness in my arms and with my hand grip strength. I was having hand tremors that required 2 hands to hold a cup of coffee.  Dressing was extremely difficult, I needed assistance to pull up my pants, buttoning and zipping them required help or adaptive tools.   I could not get my arms up high enough to put on T-shirts by myself.  I was also experiencing muscle twitches in my lower back upper arms left front neck and occasional drumming in my ears.

Walking had become extremely difficult I required a wheelchair to get to my appointments throughout the Mayo clinic during my diagnosis in December. I was fitted with a brace at that time to help address the extreme case of foot drop.

Upon my return home I was put on prescriptions of Riluzole and  Radicava.  I was asked by my neurologist if I would be interested in participating in a clinical trial for a new drug. I agreed and began the trial in March 2018. My first strength  assessment found my grip strength in my right and hand of 18 pounds my arm and leg strength was extremely low 32 pounds arm flexing was extremely weak.

I had to stop working in my store as I I no longer have the strength or stamina to stock shelves or help customers.

I had starting to notice an improvement in my strength and mobility by June 2018. In August I built a 100 square-foot deck digging post holes pouring concrete cutting lumber and attaching the deck. My wife and I began to travel again and I no longer needed a wheelchair to get around airports although I  was still using the brace at that time.  And by the end of the year in 2018 hours again able to work overseeing the daily operations of my business.

This drug has greatly improved my quality of life and that of my wife, children and grandchildren. Prior to the outbreak of the pandemic we were regularly traveling, we have walked many miles touring Europe,  China and Tibet.  Two years before I would’ve never thought this to be possible.

My health and strength seem to stabilize although I’m not back to 100%. My hand grip strength is now back to normal for a man of my age. I am fully independent and capable living a quality life. AMX 35, for me has been a life-changing drug.