Your message regarding submitting an IND to have Mytelase imported is extremely interesting. I have referred my doctor's office to it. Perhaps you could expand on your efforts & give some help.
-Should each person having an IND application submitted talk to the FDA to get their verbal agreement to accept it? Is there a particular dept or person to contact?
-Should Sanofi be requested to accept any shipments? Would they hold it only for a certain person and/or pharmacy?
-If your application is accepted is there a possibility of getting a general idea of the language your doctor's office used in completing the application? This could be quite helpful to others in their filings.
Thank you for all your work, for sharing it and for giving some of us a ray of hope.
PS-I will speak to my local MG chapter & see if they can get the national foundation to help in this matter.
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Originally Posted by reynolds_km
I am also on Mytelase. Fabulous drug, changed my life. I am so miserable on Mestinon. I was finally diagnosed with gluten intolerance and my pharmacist pointed out that Mestinon is a bromide and it agrivates my gluten intolerance. Since Mytelase is a chloride it does not bother me. I wonder why doctors don't offer Mytelase to their patients having gastro issues with Mestinon/
Not only did my issues clear up but the medication works so much better. None of that roller coaster up and down. It just works all the time. Wonderful stuff.
Okay. So the year supply Sanofi said was in the market is already used up. I did find a few bottles through Kmart a couple of months back You could try filling your prescription there.
At the time I got my bottle they had some bottles left in their warehouse. It's always been hard to get that medication in my area.
Luckily the medication is still being made in France. which means you can import the drug for your own personal use. I have investigated this. So far I have a verbal agreement from the FDA for an Investigational New Drug acception. (yeah, I know it's not new, it's a long story.) And I have a verbal agreement from Sanofi to accept the IND and import the medication.
Currently I am waiting for my doctor and the pharmacy department at the hospital he works for to submit the IND and get all the formal approvals. Government and paperwork, I don't have to tell you how long that is going to take.
My IND will only cover me. You will need to contact your doctor and ask him/her to submit an IND through the FDA on your behalf.
I don't understand why the Myasthenia Gravis foundation isn't helping on this. I tried to get some help from them. they told me to just switch to Mestinon. When I told them I could't take it they recommended Prostigmin. I told the woman the FDA made that drug illegal three years ago. And that was all the help I got.
I hope this helps you. I am only sorry I can't get a general IND for all the MG patients on this. I bet there aren't more then 20 of us in the US.
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