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Nearly 4 months after a decision was due, the FDA still has not ruled on whether Ampligen
will become the first-ever approved treatment for chronic fatigue syndrome. In August of
2009, the CEO of Hemispherx Biopharma Inc., the drug's manufacture, said that he expected
approval this fall. He apparently later said it would be "by" fall - but now fall is
officially here, and there's still no word.
There was talk all summer about what the delay meant - is there a problem with the New
Drug Application? Is there some hidden meaning to all this? Or is the Ampligen decision
just one of the many that have been put off while the FDA deals with a lot of changes?
Either way, with no word coming from the company and the FDA legally prevented from
commenting on pending applications, it's disheartening to wait...and wait...and wait,
while people who may benefit from the drug continue to suffer, and while the increased
credibility and visibility that can come with the first drug approval remain on hold.
What Ampligen Is:
Ampligen (polyu I: poly C12U) in an experimental anti-viral, immune-system modulating drug
that's been in the works for more than 30 years. It's been studied as a possible treatment
for multiple conditions, including chronic fatigue syndrome (CFS/ME), HIV/AIDS, certain
types of cancer, and, most recently, both avian flu (H5N1) and swine flu (H1N1).
Ampligen's manufacturer, Hemispherx Biopharma Inc., has applied for FDA approval of
Ampligen as an CFS/ME treatment and the decision is expected in June 2009. If it's
approved, Ampligen will be the first approved treatment for this condition.
What Ampligen Does:
Ampligen is believed to work by jump-starting your body's natural anti-viral pathway and
regulating levels of RNase L (a substance in your cells that attacks viruses), which can
be high in people with CFS/ME. It's also been shown to inhibit tumor-cell growth.
Ampligen for CFS/ME:
In clinical trials, Ampligen has been shown to improve cognition, exercise tolerance,
neuropsychological health and overall function in people with CFS/ME; decrease activity of
HHV-6 (a virus believed to be linked to CFS/ME); and decrease RNase L activity.
According to Ampligen's manufacturer, Hemispherx Biopharma Inc., more than 40,000 doses of
Ampligen were given to about 500 patients in clinical trials at more than 20 U.S. clinics.
One of those clinics, the Hunter-Hopkins Center, says 80% of its patients improved on
Ampligen, and 50% improved significantly.
Ampligen Dosage:
Ampligen is administered intravenously (I.V.). In trials and under conditional permits by
the FDA, patients typically have received 400mg of the drug twice a week. Hunter-Hopkins
recommends at least 12 months of therapy, and 18 months for the severely ill.
Ampligen Side Effects:
Possible side effects of Ampligen include:
- Mild flushing
- Tightness of the chest
- Rapid heartbeat
- Anxiety
- Shortness of breath
- Feeling hot
- Sweating
- Nausea
- Liver enzyme level changes
- Diarrhea
- Itching
- Low blood pressure
- Rash
- Arrhythmias
- Low white blood cell count
- Dizziness
- Confusion
Some patients have flu-like symptoms for a few hours after receiving a dose of the drug,
and the company says these effects typically went away after several months of treatment.
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