Austedo (deutetrabenazine) is an oral prescription medication approved to treat two conditions: Huntington’s chorea and tardive dyskinesia (TD). Austedo is classified as a vesicular monoamine transporter 2 (VMAT2) inhibitor.

VMAT2 a protein that controls transfer of chemical messengers (neurotransmitters) in the brain between nerves. These neurotransmitters help to control normal body movement or motor function.

In movement disorders such as Huntington's chorea or TD or there can be a problem with the VMAT2 system, leading to uncontrolled body movements. VMAT2 inhibitors block the action of VMAT2, lower neurotransmitter activity, and help to reduce unwanted body movements.

The safety and effectiveness of Austedo in children have not been established.

How well does Austedo work?

Huntington’s chorea is a rare, hereditary, and fatal disorder of nerve cells in the brain. The associated chorea results in involuntary, random, twisting or writhing bodily movements, and occurs in 90% of patients with Huntington's disease.

• In Phase III studies, average scores for patients in the Austedo group improved by 4.4 units compared to 1.9 units in the placebo group at week 9 and 12; the treatment effect of -2.5 units was statistically significant (p<0.0001).
• The most common side effects were somnolence (extreme drowsiness), diarrhea, dry mouth, and fatigue.
• Other agents approved to treat Huntington’s chorea include Xenazine (tetrabenazine).

Tardive dyskinesia (TD) results in involuntary movements, especially in the lower face, that can occur in patients who have taken certain antipsychotic or other neuroleptic medications. These abnormal movements include tongue thrusting, repetitive chewing, jaw swinging and/or facial grimacing. It can occur in other parts of the body, too, such as the hands, feet, legs or torso.

• Two Phase III randomized, double-blind, placebo-controlled studies assessed the effectiveness and safety of Austedo in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia. People taking Austedo were able to continue taking their mental health medications like antipsychotics or antidepressants.
• In studies, Austedo was shown to significantly reduced the involuntary movements of TD after 12 weeks of treatment when compared to placebo (an inactive agent), with improvements beginning as soon as 2 weeks.
• In one study, the AIMS score (used by researchers and doctors to measure involuntary movements in TD) was reduced by 3.3 points compared to 1.4 points with placebo.

Austedo comes as both an immediate-release and extended-release tablet.

• Austedo XR is available as a once-daily formulation approved in 6, 12, and 24 mg tablet strengths.
• Austedo is an immediate-release tablet given twice a day and comes in 6 mg, 9 mg and 12 mg strengths.
• Take Austedo with food. The tablets should be swallowed whole and not chewed, crushed, or broken.

Once-daily Austedo XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice.

Other medicines approved to treat tardive dyskinesia include Ingrezza (valbenazine).

This is not all the information you need to know about Austedo (deutetrabenazine) for safe and effective use. Review the full Austedo information here, and discuss this information and any questions you have with your doctor or other health care provider.