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.
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A, I want to tell you how much I respect the work you put into this site.
You need to know, there are times that your work shows up as a beacon in turbulent waters. Some seem to make headway dealing with FMS/ ME/CFS/Lyme I have all four. Its is difficult to keep on keepin on.. But I plan to keep on truckin! Info is KEY..Knowing that you are raising a child while dealing with any of this nightmare is impresive. There are so many that are bed ridden and Fibro fogged, I just bet your work makes the day for many.
With Deep Regard,
Judy
I really love the variety of your tweets. I am happy to know about Ampligen’s continued efforts. I would warn those who are interested in this drug to thoroughly investigate….thoroughly…..many patients overall wellbeing and/or pain got significantly worse while and/or after being on the drug.
Current research seems to point to a radioactive toxin as the (at least partial) cause; the up-regulated immune system would then be an effect not a cause.
Ampligen still a possibility? You have to be kidding.
The Company would have to do another Phase 3 trial with likely various drug doses and placebo.
This announcement was just another way to keep the company share price from continuing its march to $0.00.
Of course it’s still a possibility. Ampligen is the only drug that has consistently shown positive results in randomized controlled trials for CFS. Dozens of other drugs that have been tried flopped after only one or two small studies. It is the only drug that has ever gotten to phase III in the FDA process for the potential treatment of CFS. Unlike CBT/GET, the efficacy data for Ampligen, particularly in phase II, were based on objective outcome measures.
What the FDA is really concerned about is the long-term safety of the drug (i.e. can it cause autoimmunity?) and having biomarkers to choose appropriate candidates.
I don’t see Ampligen going the distance.
I think our best bet is Rituximab. If the clinical studies do as well as the initial phase II trial, we are looking at a 2015 recovery date!
I was in the double blind trial 10 years ago. I was one of the lucky ones that made not only a full recovery but have had no return of symptoms.
Samkatvic — do you mind me asking what type of doc you went to to get the treatment of Ampligen? I live in Texas and find that GPs won’t touch this and I don’t have a CFS specialist in my area. Thank you!