Alcobra Ltd. (ADHD) Receives Written Full Clinical Hold from FDA on MDX Phase 3

October 7, 2016 8:50 AM EDT

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Alcobra Ltd. (Nasdaq: ADHD) announced that it has received the written full clinical hold notice from the Division of Psychiatry Products of the U.S. Food and Drug Administration (FDA) in follow up to their verbal communication on the matter. As stated in Alcobra’s public communications last week, the clinical hold affects Alcobra’s Phase III clinical study of Metadoxine Extended Release (MDX) in adult patients with ADHD, known as the “MEASURE” study.

The FDA indicated in the letter that the clinical hold was placed due to electrophysiological neurologic findings in previously submitted long-term animal studies with Metadoxine. The FDA letter did not reference any clinical safety data observed in the MEASURE study or in previous human studies with MDX. The Division recommended that Alcobra schedule a meeting to discuss a plan to collect additional human safety data in its development program. Alcobra will continue to work rapidly and diligently with the FDA to seek the removal of the clinical hold and will provide an update following its meeting with the Agency.

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