Alcobra

Alcobra Ltd.
Public company
Traded as NASDAQ: ADHD
Industry Pharmaceutical industry
Headquarters Tel Aviv, Israel
Products Metadoxine Extended Release; MDX
Website www.alcobra-pharma.com

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.

Company history

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.

Products in development

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.[1]

ADHD

Alcobra has completed two Phase II trials[2][3] and one Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD.[4] Alcobra has also completed one Phase II adolescent ADHD study of Metadoxine Extended Release (MDX).[5] 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 syndrome

In December 2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment of fragile X syndrome.[6] In June 2015, Alcobra completed a Phase II clinical trial of MDX for the treatment of adolescents and adults with fragile X syndrome.[7] In September 2015, the FDA granted “Fast Track” status to Metadoxine Extended Release (MDX) for fragile X syndrome.[8]

References

  1. ↑ "Metadoxine extended release (MDX) for adult ADHD". Alcobra Ltd. 2014. Retrieved 2014-05-07.
  2. ↑ Manor, I; Ben-Hayun R; Aharon-Peretz J; Salomy D; Weizman A; Daniely Y; Meggido D; Newcorn JH; Biederman J; Adler LA (2013). "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Metadoxine in Adults with Attention-Deficit/Hyperactivity Disorder". Journal of Clinical Psychiatry. 73: 1517–1523. doi:10.4088/jcp.12m07767.
  3. ↑ Manor, I; Rubin J; Daniely Y; Adler LA (2014). "Attention Benefits After a Single Dose of Metadoxine Extended Release in Adults with Predominantly Inattentive ADHD". Postgrad Med. 126: 7–16. doi:10.3810/pgm.2014.09.2795.
  4. ↑ Weisler, R; Adler LA; Rubin J; Daniely Y; Manor I (2014). "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Metadoxine Extended Release 1400 mg Compared with Placebo Once Daily in 300 Adults with Attention-Deficit/Hyperactivity Disorder".
  5. ↑ "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.
  6. ↑ "FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome". Alcobra Ltd. 2013. Retrieved 2013-12-18.
  7. ↑ "Alcobra announces results from Phase 2 clinical trial of MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-06-24.
  8. ↑ "FDA grants fast track designation to Alcobra's MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-09-21.
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