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Alcobra updates details of FDA hold on Metadoxine for ADHD
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Alcobra Ltd. recently provided an update on the full clinical hold placed by the FDA on the development of new medications for ADHD and Fragile X syndrome.
The company reported last week that a verbally communicated clinical hold from the FDA’s Division of Psychiatry Products would affect the phase 3 study of extended-release Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate, Alcobra) for ADHD in adults.
The FDA has since issued a written full clinical hold notice, which indicated the hold was placed due to electrophysiological neurologic findings in previously submitted long-term animal studies with Metadoxine.
The FDA letter did not cite any clinical safety data from the study of Metadoxine for ADHD in adults or previous human studies with Metadoxine.
The agency recommended Alcobra schedule a meeting to develop a plan to collect additional human safety data for Metadoxine.