| 词条 | Alcobra |
| 释义 |
| name = Alcobra Ltd. | type = Public company | traded_as = NASDAQ: ARCT | industry = Pharmaceutical industry | founded = {{Start date and age|2008}} | hq_location = Tel Aviv, Israel | products = Metadoxine Extended Release (MDX); Abuse Deterrent Amphetamine Immediate Release (ADAIR) | website = {{url|www.arcturusrx.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 was headquartered in Tel Aviv, Israel, and also had a U.S. office located outside of Philadelphia in Conshohocken, Pennsylvania. Company historyAlcobra 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.[1] Products in developmentMetadoxine 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.[2]ADHDAlcobra has completed two Phase II trials[3][4] and one Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD.[5] Alcobra has also completed one Phase II adolescent ADHD study of Metadoxine Extended Release (MDX).[6] 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 syndromeIn December 2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment of fragile X syndrome.[7] In June 2015, Alcobra completed a Phase II clinical trial of MDX for the treatment of adolescents and adults with fragile X syndrome.[8] In September 2015, the FDA granted “Fast Track” status to Metadoxine Extended Release (MDX) for fragile X syndrome.[9] References1. ^{{Cite news|url=https://globenewswire.com/news-release/2017/11/16/1194029/0/en/Arcturus-Therapeutics-Announces-Completion-of-Merger-with-Alcobra-Ltd-and-Commences-Trading-on-the-Nasdaq-Global-Market.html|title=Arcturus Therapeutics Announces Completion of Merger with Alcobra Ltd. and Commences Trading on the Nasdaq Global Market|last=Inc.|first=Arcturus Therapeutics,|work=GlobeNewswire News Room|access-date=2018-05-06|language=en-US}} {{Israel NASDAQ |state=collapsed}}2. ^{{cite web|url=http://www.alcobra-pharma.com/products.cfm?productID=142236 |title=Metadoxine extended release (MDX) for adult ADHD|publisher=Alcobra Ltd|date=2014|accessdate=2014-05-07}} 3. ^{{cite journal|last=Manor|first=I|author2=Ben-Hayun R |author3=Aharon-Peretz J |author4=Salomy D |author5=Weizman A |author6=Daniely Y |author7=Meggido D |author8=Newcorn JH |author9=Biederman J |author10=Adler LA |title=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=Journal of Clinical Psychiatry|year=2013 |doi=10.4088/jcp.12m07767 |volume=73 |pages=1517–1523 |pmid=23290324}} 4. ^{{cite journal|last=Manor|first=I|author2=Rubin J |author3=Daniely Y |author4=Adler LA |title=Attention Benefits After a Single Dose of Metadoxine Extended Release in Adults with Predominantly Inattentive ADHD|journal=Postgrad Med|year=2014 |doi=10.3810/pgm.2014.09.2795 |volume=126 |pages=7–16 |pmid=25295645}} 5. ^{{cite web|last=Weisler|first=R|author2=Adler LA |author3=Rubin J |author4=Daniely Y |author5=Manor I |title=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|conference=AACAP 61st meeting|year=2014}} 6. ^{{cite web|url=http://www.alcobra-pharma.com/releasedetail.cfm?ReleaseID=900730 |title=Alcobra's MDX Meets Primary Endpoint in Phase II Safety and Tolerability Clinical Trial in Adolescents With ADHD|publisher=Alcobra Ltd|date=2015|accessdate=2015-03-10}} 7. ^{{cite web|url=http://www.marketwatch.com/story/fda-grants-orphan-drug-status-to-metadoxine-in-fragile-x-syndrome-2013-12-18 |title=FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome|publisher=Alcobra Ltd|date=2013|accessdate=2013-12-18}} 8. ^{{cite web|url=http://www.alcobra-pharma.com/releasedetail.cfm?ReleaseID=919218 |title=Alcobra announces results from Phase 2 clinical trial of MDX for Fragile X Syndrome|publisher=Alcobra Ltd|date=2015|accessdate=2015-06-24}} 9. ^{{cite web|url=http://www.alcobra-pharma.com/releasedetail.cfm?ReleaseID=932364 |title=FDA grants fast track designation to Alcobra's MDX for Fragile X Syndrome|publisher=Alcobra Ltd|date=2015|accessdate=2015-09-21}} 3 : Pharmaceutical companies of Israel|Pharmaceutics|Companies listed on NASDAQ |
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