Alcobra Ltd. is a public, specialty pharmaceutical company. The company is focused on the development of new medications to help patients with cognitive disorders, including attention deficit hyperactivity disorder (ADHD) and fragile X syndrome.
Alcobra is headquartered in Tel Aviv, Israel, and also has a U.S. office located outside of Philadelphia in Plymouth Meeting, Pennsylvania.
Alcobra was founded in 2008. In 2013, the company completed an initial public offering (IPO) and trades under the symbol “ADHD” on the NASDAQ stock exchange.
Metadoxine Extended Release (MDX) is the company’s lead investigational product candidate. Metadoxine Extended Release is a monoamine-independent modulator of GABA (gamma-aminobutyric acid) transmission. The mechanism of action does not directly affect dopamine or norepinephrine. The compound is not a psychostimulant. Metadoxine has shown no potential for abuse or addiction in studies completed to date.
Alcobra has completed two Phase II trials and one Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD. Alcobra has also completed one Phase II adolescent ADHD study of Metadoxine Extended Release (MDX). In mid-2015, Alcobra began a second Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD, called the MEASURE study.
In December 2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment of fragile X syndrome. In June 2015, Alcobra completed a Phase II clinical trial of MDX for the treatment of adolescents and adults with fragile X syndrome. In September 2015, the FDA granted “Fast Track” status to Metadoxine Extended Release (MDX) for fragile X syndrome.