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FDA hold halts phase 3 study of ADHD, Fragile X syndrome treatment
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Alcobra, Ltd. received verbal notice from the FDA’s Division of Psychiatry Products that a full clinical hold was placed on the Investigational New Drug applications for extended-release metadoxine for ADHD and Fragile X syndrome, according to a company press release.
The clinical hold will affect an ongoing phase 3 study of extended-release metadoxine (MDX), an oral formulation (pyridoxol L-2-pyrrolidone-5-carboxylate), among approximately 500 adults with ADHD.
According to the release, Alcobra has not yet received written notice of the clinical hold from the FDA. However, verbal communications indicated that the clinical hold is due to adverse neurological findings from a pre-clinical study and was not based on clinical safety data from the ongoing study or previous clinical studies of MDX.
Alcobra is working with the FDA to pursue removal of the clinical hold.