FDA denies drug for Chronic Fatigue Syndrome
RENO, Nev. (KRNV & MyNews4.com) -- A drug some patients say they rely on to combat a debilitating disease has been denied by the U.S. Food and Drug Administration.
Robert Miller of Reno has battled Chronic Fatigue Syndrome for over 20 years and he says Ampligen has changed his life. Ampligen made by Hemispherx Biopharma, Inc. has been going through clinical trials for about 20 years and has recently been denied by the FDA.Miller has been on Ampligen since 1999, and moved his family twice in 14 years to access the clinical trial.
"Now the 100 or so patients on Ampligen like me risk losing the only treatment that clearly works for us. Ampligen transforms me from bedridden to being able to care for my twin boys," Miller says.
The following is a statement released by Hemispherx, "Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analysis."
CFS is a disorder according to the National Institute of Health that causes extreme fatigue, but not the kind of tired feeling that goes away after you rest instead it lasts for long periods of time and limits ordinary activity. At least one million Americans are effected by CFS. Miller says it also causes extreme chronic pain in joints and throughout a patient's body.
In the release Hemispherx says the FDA made recommendations, "the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. "
Miller is asking Secretary of Health Kathleen Sebelius to conduct clinical trials of Ampligen at the National Institutes of Health.