FDA slaps a full clinical hold on Alcobra’s troubled lead drug for ADHD, Fragile X

Following a series of clinical setbacks and missteps, Alcobra $ADHD says its lead drug MDX has been put on a full clinical hold by the FDA “due to adverse neurological findings in a pre-clinical study.”

The hold will stop its ongoing Phase III study in adult patients with ADHD, according to the Israeli biotech, which reported at the end of August that it had recruited 474 patients for the study.

Alcobra’s brief statement included this:

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.

Jefferies analyst Biren Amin noted this morning that “these data were sent to FDA in March 2016 but it seems the agency just only now got around to taking action and maybe due in part to a new non-clinical team member joining the FDA recently. Pyridoxine, a cmpd similar to MDX, has shown slowing of nerve conduction in rats when dosed at high levels.”

The biotech has followed a long and twisting path on MDX. The treatment failed a Phase II study for Fragile X syndrome last summer, which followed a late-stage failure in ADHD, which the company tried to spin as a success after selectively pruning patients.

Their drug metadoxine (MDX) is described as a nonstimulant GABA modulator.

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