Drug company Hemispherx Biopharma, Inc. announces applications for its experimental therapeutic drug Ampligen to be approved as a treatment for Chronic Fatigue Syndrome.
The company said yesterday that it had filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and was also moving forward with applications in other countries. Should the applications be approved it would be a landmark as Ampligen would become the first approved therapy for Chronic Fatigue Syndrome (CFS).
Currently the only recommendations for CFS are the use of cognitive behavioural therapy (CBT) and specially designed graded exercise programs to manage the condition.
It's reported that Hemispherx Biopharma's NDA submission includes four well-controlled clinical trials involving CFS patients. The trials are said to include more than 1,200 patients who were given a total of approximately 90,000 doses of Ampligen.