Alcobra Ltd. (NASDAQ: ADHD), an emerging pharmaceutical firm focused on the development of novel medications to treat cognitive disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced earlier today that it has received a full clinical hold notice from the U.S. Food and Drug Administration’s Division of Psychiatry Products regarding its phase III clinical study of Metadoxine Extended Release (MDX) for the treatment of ADHD in adult patients. The letter indicates that the FDA hold in in response to electrophysiological neurologic findings in previously submitted long-term animal studies of Metadoxine. The FDA has recommended that Alcobra schedule a meeting with its Division of Psychiatry Products in order to formulate a plan to collect additional human safety data, as needed to remove the clinical hold and proceed with its phase III MEASURE study.
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About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX, a proprietary drug candidate, to treat cognitive disorders including ADHD and Fragile X Syndrome. For more information, please visit the company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
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