Abstract
BACKGROUND • Metadoxine is an ion-pair salt of pyridoxine (vitamin B6 and a precursor of pyridoxal phosphate) and 2-pyrrolidone-5-carboxylate (PCA, also known as L-PGA) that has been used for more than 30 years to treat acute alcohol intoxication and chronic alcoholic liver disease1 • Pyridoxal phosphate−dependent enzymes are required for the biosynthesis of 4 key neurotransmitters: serotonin (5-hydroxytryptamine [5-HT]), epinephrine, norepinephrine (NE), and gamma-aminobutyric acid (GABA)2 • Although the exact mechanism of action of metadoxine is unknown, metadoxine extended-release (MG01CI, MDX) demonstrated cognitive enhancing effects in a phase 2b study of 120 adults with attention-deficit/hyperactivity disorder (ADHD),1,3 and a phase 2b study of 36 adults with predominantly inattentive ADHD.4 MDX is in clinical development for the treatment of ADHD (a 300-patient phase 3 study with adult ADHD is ongoing) and Fragile X syndrome (FXS) • Improvements in cognitive function, working memory, and social interaction following treatment with metadoxine in a valid mouse model of FXS correlated with normalization of biochemical markers reflective of neuronal signaling pathways and oxidative stress5 • Key results are presented from a series of experiments designed to further characterize the mechanism of action of metadoxine
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