FDA Approves Deutetrabenazine for Tardive Dyskinesia

It becomes only the second FDA-approved drug for the movement disorder, following valbenazine (Ingrezza) earlier this year.

The Tardive dyskinesia (TD) treatment count just doubled.

Deutetrabenazine (AUSTEDO) tablets has been approved by the US Food and Drug Administration (FDA) for the treatment of TD. It becomes only the second FDA-approved drug for the movement disorder, following valbenazine (Ingrezza) earlier this year.

The drug was approved for treating chorea associated with Huntington Disease (HD) in April. The oral, small molecule vesicular monoamine 2 transporter (VMAT2) inhibitor regulates dopamine levels in the brain. It is created by Israel-based company Teva Pharmaceutical Industries.

Prior to approval, 2 fixed doses of deutetrabenazine for TD showed efficacy and safety in TD treatment, versus placebo in a Phase III trial involving 298 patients.

The study, AIM-TD — AIMS standing for the Abnormal Involuntary Movement Scale — screened 12mg, 24 mg, and 36mg doses of the drug in TD patients for nearly 2 years. The findings resulted in researchers advocating for individualized regimens of deutetrabenazine for TD control and tolerance, with 24mg and 36mg doses proving significant in reducing the disorder’s conditions.

That said, physicians are advised to monitor patient dosage rates early into treatment. Francis Walker, MD, professor of neurology at the Center for Public Health Genomics at Wake Forest University told MD Magazine that in his experience, dose changes have been needed for movement disorder treatments.

“The goal with most medications is to use the lowest dose for a clinically relevant response,” Walker said. “We want to advise clinicians that over time, the general tendency should be to re-evaluate doses somewhat frequently. Temporary dose reductions are also a reasonable approach.”

Teva officials noted the dosing versatility of deutertrabenazine in a statement announcing the approval Wednesday.

“We are pleased to bring forward this second indication for AUSTEDO to treat the underserved tardive dyskinesia population,” Michael Hayden, MD, PhD, president of Global R&D and chief scientific officer at Teva, said. “We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”

In comparing deutetrabenazine to valbenazine for TD, Walker said drug costs and eventual results in clinical use will determine the 2 drugs’ most significant differences.

“It looks like they’ve done long term studies with valbenazine that are reassuring,” Walker said. “Our experience is that long term, these drugs are fairly stable in their effects, and over time you can adjust dosages.”

Walker added that caution must be taken when considering the long-term side effects of TD treatment.

“Depression and Parkinson’s are associated with this class of drug, and careful monitoring is what will make the difference,” Walker said.

A press release regarding the decision was made available.

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