NEWSBRIEF: Drug manufacturer Hemispherx Biopharma Inc. has announced that the U.S. FDA has tentatively scheduled an Advisory Committee meeting to talk about Ampligen as a potential treatment for chronic fatigue syndrome.
Advisory Committees review the evidence and make recommendations. While the recommendations don't have to be followed, they usually are.
The FDA rejected Ampligen in late 2009, but at the time it offered guidance to Hemispherx about how it could improve the application. The company has submitted further data and the process is once again moving forward.
Ampligen is an immune-system modulator and anti-viral medication that's been tested against multiple illness for 30+ years without ever making it onto the market. If approved, it would be the first approved medication for chronic fatigue syndrome. The FDA is scheduled to complete its review by February 2, 2013.
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So true I am taking Vyvance a time release capsule that release in the blood other than stomic than the adderal same medicine just a time release. I have to to take this to function half the day. Someday it may not work well. I sense no addition. I wish and I have gone off but this has been the only medicine that helpful. I can not drink coffee all day it hurts my stomic. I hope ampligem gets approved soon
Hemispherx’s Ampligen Rehash Unlikely to Impress FDA – Sept 29, 2012
3 pages of interesting reading.
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Also at the end of the article read more about Ampligen:
Hemispherx’s CFS Drug Is a Long Shot
Hemispherx Builds False Hope on Old Data
http://www.thestreet.com/story/11720256/1/hemispherxs-ampligen-rehash-unlikely-to-impress-fda.html
I too take Vyvanse. It’s the ONLY medication that makes a difference to where I can get out of bed and function. I take 70 mg in the morning with a 40 mg booster in the afternoon. I don’t have insurance and it’s very expensive, but I just can’t do without it. I hope this new med makes it through and won’t be outrageously expensive.
Those of us with a chronic viral infection need options. We need help.