Chronic Fatigue Rx Has Another Setback

Ampligen for chronic fatigue syndrome was rejected by an advisory panel to the FDA

(RxWiki News) An advisory panel to the US Food and Drug Administration (FDA) did not support Ampligen (rintatolimod) as safe and effective. The drug will not likely gain FDA approval at this time.

Recent press reports say the panel voted against the drug because the data did not show it to be safe or effective. The FDA will announce its official decision in February.

"Talk to your doctor if you're feeling fatigued."

The arthritis advisory committee to the FDA met on December 20 to discuss and make recommendations about drug applications. News reports vary on the specifics, but a majority of the panel members voted against the drug. There was also missing safety info. And the good effects of the drug seemed to be small.

Nature News reports that an FDA representative said that the Ampligen application had some problems with the data. Those problems called into question the accuracy of other aspects of the report.

The Wall Street Journal reports that at least one of the panel members said that they would like to see more data on this drug in the future.

People who were in the trials for Ampligen liked the drug. The effects were small, but people reported that it was enough to make a difference for them.

Ampligen has been under development to treat chronic fatigue syndrome for many years. It is made by Hemispherx Biopharma, Inc.

It is not clear, at this time, whether or not Hemispherx plans to do more trials and resubmit their application.

Chronic fatigue syndrome is characterized by extreme fatigue, lack of stamina, concentration issues and memory problems. There are no approved treatments for this disorder.

Official reports from the FDA advisory panel are not available yet.  This information was first reported in Nature News and the Wall Street Journal.

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Review Date: 
December 21, 2012