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Adrienne Dellwo

FDA Rejects Ampligen for Chronic Fatigue Syndrome

By February 5, 2013

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NEWSBRIEF: The decision is in, and the FDA has once again rejected the drug Ampligen (rintatolimod) for chronic fatigue syndrome, leaving this seriously debilitating illness with no approved treatments.

The FDA said the company did not provide sufficient data on either effectiveness or safety. While the rejection was expected by many, it represented a major step forward and a lot of patients, doctors and advocates were holding out hope.

However, when it comes to the drug-approval process, it's rarely "over." Ampligen's manufacturer, Hemispherx Biopharma Inc., has already said it will appeal the ruling. In the FDA's Complete Response Letter to the company, it detailed what additional data it would need in order to reconsider, which included:

  • One or more additional clinical trials,
  • Several non-clinical studies,
  • Multiple data analyses.

Hemispherx said it believes the company did show adequate safety and efficacy data. Company officials said they plan to request an end-of-review conference with the FDA, after which it will submit an appeal.

Meanwhile, millions of people with chronic fatigue syndrome will continue to wonder whether Ampligen would work for them. While no drug helps everyone with this complex and highly variable condition, it has helped some people regain their function and quality of life.

Are you disappointed by the FDA's decision? Would you try Ampligen if it were available? Leave your comments below!

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Comments
February 6, 2013 at 1:44 pm
(1) George says:

Hopefully it is over and the management of Hemispherx is put in jail for 30 years of fraud.

Ampligen was once proposed for use in cigarettes. Ampligen has been proposed for uses in over 30 conditions. Management has paid themselves millions while continually diluting the stock. The Company has two drugs, Ampllgen and Alferon. Alferon is used to treat genital warts and the Company no longer makes the drug.

As for Ampligen, there have been no new trials for years and the effectiveness of the drug is based on a treadmill test. Anyone with CFS knows that you ability to perform on a treadmill varies from day to day and improvement of a few second on a treadmill proves nothing.

Enough.

February 8, 2013 at 8:13 pm
(2) karen hart says:

Robert Miller is on the 10th day of his hunger strike. Robert Miller has Chronic Fatigue Syndrome. He requests the FDA approve Ampligen for PwCFS.. Ampligen has helped him tremendously. He has a Facebook page, Hunger strike for Ampligen Approval for CFS

http://www.facebook.com/HungerStrikeForAmpligen?fref=ts

February 14, 2013 at 1:24 am
(3) georgia senna says:

I know the FDA is unreasonable & intractable about approval of medications that can bring relief for those who are suffering; however, after being diagnosed with FMS &CFS for 10 years I am so glad thatthe FDA is very cautious about approving drugs. When my Dr. prescribes a medication for me I am glad that I can rely on the process that determines whether a drug will not only help me, but won’t destroy my body in the process. I don’t need one more health issue to have to cope with.

February 14, 2013 at 1:24 am
(4) georgia senna says:

I know the FDA is unreasonable & intractable about approval of medications that can bring relief for those who are suffering; however, after being diagnosed with FMS &CFS for 10 years I am so glad thatthe FDA is very cautious about approving drugs. When my Dr. prescribes a medication for me I am glad that I can rely on the process that determines whether a drug will not only help me, but won’t destroy my body in the process. I don’t need one more health issue to have to cope with.

February 25, 2014 at 1:51 am
(5) Anji says:

CFS has taken most of my life from me.

I would have nothing to lose by trialling or taking this drug and would do so in a heartbeat.

They MUST approve this drug if there is half a chance of recovery for sufferers of this dreadful disease. Any other decision is cruel.

Anji

March 11, 2014 at 4:32 pm
(6) KV says:

I hate that our government continues to reject any medication that might help those of us with CFIDS who are completely debilitated and housebound while rejecting any type of legalized euthanasia.

I am getting worse and am so debilitated I might as well be in a coma. Not only do I not feel alive but as if I’m at death’s door. I am extremely depressed and getting more so because I have no physical or mental energy to do what I want or what I need to do.

I don’t think there will ever be a treatment for this that is approved by the FDA. I continue to hope that I will simply die in my sleep.

April 20, 2014 at 5:18 pm
(7) lisa says:

kV,
I understand how you feel. I had a severe mono infection 6 years ago and have not been well since…I know stress is a huge factor for flares and I lost my mother almost 2 yrs ago and have been almost nonstop fatigue…I have been thinking I would rather not be here on earth a lot these days and very depressed…the only people that understand this condition are the people that have it!
P.S. see if your doctor will prescribe adderall…I couldn’t work with out it..
Peace and love to you,
Lisa

May 2, 2014 at 1:32 am
(8) PP says:

It is truly a shame that the FDA continues to be so close minded. For those that say they feel so “secure” in the FDA’s process of approval….please don’t kid yourself. The approval process of the so-called CFIDS & FM approved drugs Lyrica and Cymbalta didn’t necessarily show good or great results. Chances are that these big pharma companies paid off the FDA. In fact the side effects of these drugs are absolutely rotten!

If anyone has some a minute amount of research on Ampligen you can find that those who have been able to be lucky enough to find it receive almost immediate relief from their overwhelming fatigue. Until you have lived with this horrendous disease (and chances are none of the idiots on the FDA ever have) you will never know how devastating the impact is to your life and the lives of those you love.

What the FDA is doing is borderline criminal and I venture to say it is because their pockets are not being lined by big pharma. We can’t let this happen. We must continue to support the process and put pressure on them when the approval goes forward again!!

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