• Skip to primary navigation
  • Skip to content
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Articles
  • Resources
  • Contact

Chronic Fatigue Syndrome

Chronic Fatigue Syndrome, Fibromyalgia, and IC Disease

  • Home
  • Fibromyalgia
    • Fibromyalgia Awareness
    • Fibromyalgia Research
    • Fibromyalgia Symptoms
    • Fibromyalgia Treatments
  • Chronic Fatigue
    • Awareness
    • Pediatric CFS
    • Research
    • Symptoms
    • Treatments
  • Chronic Illnesses
    • Cancer
    • Interstitial Cystitis
    • Irritable Bowel Syndrome
    • Chronic Pain
    • Vitamin D Deficiency
    • Women’s Health
  • Sandy’s Journey
  • Coping Corner
    • Disability
You are here: Home / ME/CFS / Treatments / FDA Accepts Antiviral Drug Ampligen For Review To Treat ME/CFS

FDA Accepts Antiviral Drug Ampligen For Review To Treat ME/CFS

4 Comments

The FDA has approved to review the medication, Ampligen, as potentially the first prescription drug to treat ME/CFS.  The drug is being reviewed in particular to treat patients who have severe ME/CFS.  Ampligen has been in development and testing now for 30 years as a treatment for Chronic Fatigue Syndrome.

Ampligen, which is used intravenously, has been approved in Canada and Belgium for ME/CFS treatment since 1996.  The drug is meant to be used twice a week for at least a year.

AmpligenR (polyI:polyC12U) – still allowed only in specific clinical trial settings conducted under U.S. governmental authorization – is termed a nucleic acid drug, designed to modulate the body’s immune system. Its mechanism of action in ME/CFS is not entirely clear, but it is thought to act on two enzyme systems so as to help the immune system destroy viral RNA and speed the death of virus-affected cells. In particular it may downregulate an anti-viral pathway which research suggests has become upregulated  in certain ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).

 

The drug’s maker, Philadelphia-based Hemispherx Biopharma, submitted a New Drug Application to the FDA in 2007, and had been asked to answer a series of questions. The FDA’s acceptance of the drug for safety/efficacy review was based on receipt of the requested data. The maker reportedly suggests it is also researching oral delivery of the drug. A “Who’s-Who” of the world’s leading ME/CFS specialists have participated in AmpligenR trials over the years.

Source

Filed Under: Treatments Tagged With: Ampligen, ME/CFS

Reader Interactions

Comments

  1. Pat Yutko says

    October 14, 2008 at 9:03 am

    Hi,
    Can ampligen be used to treat the pain of fibromyalgia? Are there any clinical trial in New Jersey? What are the side effects, risks, benefits?
    Pat

    Reply
  2. Tala says

    November 5, 2008 at 6:11 pm

    Thanks for the info!

    Reply
  3. Mirabell Menin says

    May 29, 2009 at 4:14 pm

    Is it possible for a private doctor in Europe, treating ME/CFS patients, to order this drug for his patients?

    Reply
    • Sandy Robinson says

      May 29, 2009 at 8:46 pm

      Hi Mirabell, Sorry but I can’t answer your question. Maybe someone else reading this will know something.

      Reply

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Primary Sidebar

find us on facebook

Recent Comments

  • meticore on CFS & Fibromyalgia Links
  • meticore on ME/CFS & Fibromyalgia Around the Web
  • Lydia on Eosinophilic Cystitis
  • Pifer on Rosacea: Related to ME/CFS & FM?
  • Wolf on Noise Is Causing Panic Attacks
  • Mich on Living Daily with Pain Around the Clock
  • Frida on Presentation/Online Q & A with XMRV Researcher, Dr. Judy Mikovits

Secondary Sidebar

Sub Topics

  • Fibromyalgia Awareness
  • Fibromyalgia Research
  • Fibromyalgia Symptoms
  • Fibromyalgia Treatments

Copyright © 2022 · FightingFatigue.org