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rintatolimod
Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of chronic fatigue syndrome.〔 However, there is only low-quality evidence that it can improve the people's ability to exercise.〔
It is a immunomodulatory double stranded RNA drug synthesized in the 1970s and manufactured by Hemispherx Biopharma.〔(Official website )〕
Although Ampligen was cleared for use in Canada in 1997,〔http://wwcoco.com/cfids/ampligen2.html〕 and obtained orphan drug status for treatment of CFS in the European Union in 2000,〔http://www.cfsfacts.org/2009/12/facts-about-ampligen-research-in-cfs.html〕 it is so far without FDA approval and therefore classed as experimental in the United States. In 2007 it filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS,〔(Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment of Chronic Fatigue Syndrome NDA of investigational drug includes four well-controlled trials, more than 1,200 trial subjects and 90,000 doses )〕 but this was rejected in December 2009 because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy"〔http://www.thestreet.com/_yahoo/story/10636318/1/hemispherxs-ampligen-dealt-fda-blow.html〕 and "because of clinical, statistical, clinical pharmacology, nonclinical, product quality, and facilities inspection deficiencies."〔(Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS): Questions and Answers ) - Food and Drug Administration, 5 February 2013〕 The FDA requested Hemispherx conduct at least one additional controlled trial to demonstrate efficacy in treating CFS. In August 2012 Hemispherx submitted further analyses of the original clinical trial data, although did not submit additional trials for review. Four months later a committee of the FDA voted 8-5 against approval for rintatolimod, again citing insufficient data.〔
==Medical uses==
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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