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Second Tardive Dyskinesia Drug Okayed

— Deutetrabenazine (Austedo) joins valbenazine (Ingrezza) in TD indication

MedpageToday

The FDA approved a second drug for treating tardive dyskinesia in adults: Teva's deutetrabenazine (Austedo), which was approved in April for Huntington's chorea, .

Neurocrine's valbenazine (Ingrezza) was also approved last April to treat tardive dyskinesia. The FDA for bringing the drug to market in the pages of the New England Journal of Medicine.

Both drugs work by inhibiting the vesicular monoamine 2 transporter (VMAT2) pathway, which plays a role in regulating dopamine levels in the brain.

Teva said the condition, characterized by involuntary and repetitive body movements, affects about 500,000 people in the U.S. and is often a side effect of antipsychotics.

Approval was based on results from the phase III AIM-TD and ARM-TD trials, which showed the drug reduced the severity of abnormal involuntary movements associated with tardive dyskinesia.

A similar drug, tetrabenazine, has been used off-label to treat tardive dyskinesia, though clinicians have raised concerns about high peak concentrations and plasma fluctuations, with consequent adverse effects. Deutetrabenazine substitutes deuterium for hydrogen atoms in the drug molecule, altering its pharmacokinetics enough to mitigate those problems.

Other strategies have included lowering the dose of the drug that's causing the problem, or switching to another drug. But now, clinicians also have two FDA-approved tardive dyskinesia drugs to choose from.