Ampligen® Takes Another Step Toward Market
Hemispherx Biopharma reports it is readying an FDA New Drug Approval application for permission to market its antiviral drug Ampligen®, for the treatment of Chronic Fatigue Syndrome.
This follows recent completion of a Phase III study with CFS patients. The as-yet-unpublished results of this latest trial reportedly allowed CFS patients who received Ampligen® for 40 weeks to increase their exercise tolerance by an average of 15 percent compared with another group of CFS patients who received a placebo (fake dose). If the FDA’s follow-up research supports approval of Ampligen® as a CFS therapeutic, Hemispherx projects it will cost $15,000 to $20,000 per patient per year, according to a recent article in Science News.
The co-inventor of Ampligen®, William A. Carter, MD, pioneered the clinical development of the antiviral therapy interferon, which now pulls down annual sales of $2 billion-plus.