In 2012, the Solve ME/CFS Initiative—under its former organization as the CFIDS Association of America—funded Biovista Inc., a private drug development services company, to identify potential drugs that might be repurposed to ameliorate ME/CFS symptoms. Biovista identified two FDA-approved drugs that might have applicability for ME/CFS.
Since the completion of the work, the possibility of raising funds to further develop a treatment based on this combination has been explored. In view of the recent effort for National Institutes of Health funding for ME/CFS, the research and patient community may be better served by making this initial finding known to the public now.
Low Dose Naltrexone (LDN) and Trazodone are the two drugs identified through a bioinformatics analysis as potential treatment in ME/CFS. In its analysis, the company employed Drug Repurposing, the process of finding new indications for existing drugs, to identify compounds for the treatment of ME/CFS, focusing on case-defining symptoms, such as cognitive impairment and unrefreshing sleep among others.
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The method entailed using a proprietary in silico platform—that is, based on an algorithm, not an experimental biology investigation—called Clinical Outcome Search Space (COSS) to predict compounds relevant to ME/CFS Symptoms. COSS analysis is a literature-based modeling approach for making predictions that uses two basic steps. The first step is the creation of multi-dimensional profiles of biological entities of interest such as drugs, disease, genes, proteins and adverse events. The second step is the ranking and prediction process.
Naltrexone is an FDA-approved drug for the use of opioids addiction. As an opioids receptor antagonist, it binds opioids receptors with the net effect of reversing or blocking the opioids effects. Low Dose Naltrexone has been used as an “off-label” treatment for some conditions unrelated to addiction or intoxication, like Multiple Sclerosis and Fibromyalgia. Trazadone is an antianxiety drug with sleep-inducing benefits. It belongs to the serotonin antagonist class of drugs and has been used by many ME/CFS specialists to help in the management of ME/CFS symptoms.
It is important to emphasize that the outcome of this research is the result of computer-assisted methodologies only; these drugs have not been tested by the company through experimental investigations for safety, synergy or efficacy with regard to ME/CFS. Making these two drugs known is in no way an endorsement of their use. No clinical trials have been undertaken, and dosage and ratios are as yet unknown.
That said, many patients have experience with Trazodone and LDN since multiple physicians treating ME/CFS prescribe them. The familiarity of these two drugs could warrant further investigation.