Monomethyl fumarate (Bafiertam)
Monomethyl fumarate (Bafiertam) is an oral DMT taken twice daily for relapsing forms of MS. It is a fumarate-type medication, as is dimethyl fumarate (DMF). Monomethyl fumarate (MMF) was granted FDA approval after it demonstrated that it is a “bioequivalent alternative” to DMF. The active ingredient and site of action of MMF does not differ significantly from DMF.
A single-dose, open-label, randomized, 2-way crossover study, evaluating the comparative pharmacokinetics of the test product MMF versus the reference product DMF, under fasting conditions, was conducted. The study population was 50 healthy adult patients. A five-week study has been completed, but results have not been published (NCT04570670). Additionally, a trial investigating the GI tolerability of bioequivalent doses of MMF and DMF in 210 healthy patients has been conducted. However, the results of this study have not been published (NCT04022473). To date there have been no trials of MMF in people with MS.
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