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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.
|Traded as||NASDAQ: ARCT|
|Headquarters||Tel Aviv, Israel|
|Products||Metadoxine Extended Release (MDX); Abuse Deterrent Amphetamine Immediate Release (ADAIR)|
Alcobra was headquartered in Tel Aviv, Israel, and also had a U.S. office located outside of Philadelphia in Conshohocken, Pennsylvania.
Alcobra was founded in 2008. In 2013, the company completed an initial public offering (IPO) and traded under the symbol “ADHD” on the NASDAQ stock exchange. In November 2017, Alcobra merged with Arcturus Therapeutics, a San Diego-based biotech that focuses on development of RNA medicines.
Products in developmentEdit
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.
Fragile X syndromeEdit
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.
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- "Alcobra's MDX Meets Primary Endpoint in Phase II Safety and Tolerability Clinical Trial in Adolescents With ADHD". Alcobra Ltd. 2015. Retrieved 2015-03-10.
- "FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome". Alcobra Ltd. 2013. Retrieved 2013-12-18.
- "Alcobra announces results from Phase 2 clinical trial of MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-06-24.
- "FDA grants fast track designation to Alcobra's MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-09-21.