FDA places clinical hold on Phase III trial MEASURE of MDX in ADHD.-Alcobra

Alcobra announced that it has received verbal notice from the Division of Psychiatry Products of the FDA that a full clinical hold has been placed on its Investigational New Drug (IND) applications for MDX in ADHD and Fragile X Syndrome. The clinical hold affects Alcobra�s ongoing Phase III clinical study of MDX in adult patients with ADHD, known as the �MEASURE� study.

Alcobra has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study. The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX. Alcobra plans to work diligently with the FDA to seek the removal of the clinical hold.