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Ampligen for Chronic Fatigue Syndrome: still a possibility

Thursday 26 January 2012


From's Adrienne Dellwo:


TabletsAmpligen for Chronic Fatigue Syndrome: Still a Possibility

By Adrienne Dellwo, Guide
January 21, 2012

NEWSBRIEF: After being rejected 2 years ago, the drug that many thought would become the first FDA-approved treatment for chronic fatigue syndrome (ME/CFS) apparently isn't off the table. Hemispherx Biopharma Inc. says the FDA has granted an extension that could allow them to make another run at getting Ampligen (rintatolimod) approved.

Here's a little about how the process works: drug companies trying to get a new product approved submit a New Drug Application (NDA) to the FDA. A rejection doesn't mean, "No, go away." It's more of a, "Not based on the current application." When Ampligen was rejected in December 2009, the FDA detailed for the company what more it would need in order to strengthen its application. The company then has a limited time to submit information under the NDA. Ampligen's NDA was due to expire, but now the company has more time to get information in without having to start a new NDA.

Ampligen is a controversial drug. For more than 3 decades, it's been tested against a wide array of illnesses with little success. However, results were better with ME/CFS. Critics say the company is desperately trying to make some money on a failed project. However, research has showed promise. For the few people who've been allowed, under special conditions, to take Ampligen, results are mixed - some have no improvement or can't tolerate the drug, while some feel better. That's true of any ME/CFS treatment, and I suspect it will be until we have proper subgrouping. (Many researchers believe that several types of ME/CFS exist that each need a different treatment protocol.)

Ampligen is an immune-system modulator and anti-viral. It's believed to work by jump-starting your body's natural anti-viral pathway.

Learn more about Ampligen

Learn more or join the conversation!


ME/CFS, Viruses & the Immune System
ME/CFS Treatment Options
What Causes ME/CFS?


The above, with comments, originally appeared here.



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