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We are an emerging biopharmaceutical company primarily focused on the development and commercialization of our proprietary drug, METADOXINE EXTENDED RELEASE (MDX), to treat Attention Deficit Hyperactivity Disorder (ADHD) and other cognitive disorders.
METADOXINE EXTENDED RELEASE is not a stimulant; it works through a different mechanism of action than other ADHD treatments. Alcobra published the outcomes from a 120-patient double-blind Phase IIb study that showed significant improvement in clinical ADHD symptoms in adults with ADHD, and also showed favorable tolerability. The trial met all primary and secondary clinical endpoints showing statistically significant improvement compared to the placebo-treated control group.
In December 2013, Alcobra announced highly statistically significant positive results from a Phase IIb clinical trial with MDX in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PI-ADHD). This Phase IIb trial was a randomized, double-blind, placebo-controlled, cross-over single center study that enrolled 36 adult subjects with PI-ADHD at Geha Mental Health Center in Petach Tikva, Israel. The study provides confirmation of the immediate effects of a single 1,400 mg dose of MG01CI in adults.
Our objective is to develop and commercialize proprietary pharmaceutical products for treatment of central nervous system disorders, and cognitive dysfunctions in particular.
We intend to conduct additional clinical trials for our most advanced product (MDX) and, if those trials are successful, seek marketing approval from the U.S. Food and Drug Administration (FDA), and other worldwide regulatory bodies for MDX for the treatment of ADHD in adults and children. We also plan to advance clinical studies and commercialization plans for MDX in additional indications of cognitive dysfunction where there is significant unmet clinical need such as Fragile X Syndrome.