Hemispherx Biopharma, Inc. recently filed a new drug application with the FDA to market Ampligen as a treatment for Chronic Fatigue Syndrome. Ampligen was developed and discovered at Johns Hopkins University and before it was used experimentally for CFS, it was considered a potential treatment for AIDS and cancer. Ampligen has been in the developing and testing stages for over 30 years.
Ampligen has received various designations from the FDA, including Orphan Drug Product Designation and Emergency (compassionate) Cost Recovery Sales Authorization (FDA). Four pivotal trialswith data on more than 1,200 subjects evaluated with approximately 90,000 dose administrationsare being reported in the new drug application to the FDA.
This is what I found on the use of Ampligen related to CFS (Source: Immunesupport.com):
Patients with CFS use large quantities of drugs to alleviate the symptoms associated with CFS. The concomitant use of drugs to treat symptoms of CFS was significantly less in the Ampligen arms of both the Phase 2 and Phase 3 controlled trials.
Ampligen treatment in chronically debilitated CFS populations has demonstrated significant improvement in physical well being and quality of life that can be linked with dysregulation of gene expression associated with energy metabolism.
The improvement in exercise duration is significantly correlated to improvement in oxygen utilization and physical performance.
When was the NDA applied for?