The US Food and Drug Administration (FDA) has approved deutetrabenazine for the treatment of chorea associated with Huntington’s disease.1
The drug, which will be marketed as Austedo™ (Teva), is the first deuterated drug to win approval, allowing for a slower drug breakdown in patients. Deutetrabenazine is a small molecule inhibitor of vesicular monoamine 2 transporter, which helps regulate dopamine levels in the brain.
Only the second drug approval for Huntington’s, deutetrabenazine helps to control the involuntary twisting and writhing experienced by up to 90% of patients with Huntington’s.
Efficacy was demonstrated in a double-blind, placebo-controlled, multicenter trial in 90 patients with Huntington’s.2 Those who were assigned deutetrabenazine experienced a statistically significant improvement in total maximal chorea score compared with those who received placebo.
Although the most common adverse effects are somnolence, diarrhea, dry mouth, and fatigue, the drug also comes with a black box warning for increased risk for depression and suicidality. Treatment with deutetrabenazine is also associated with akathisia, agitation, and restlessness and may cause parkinsonism in some patients.
Patients with hepatic impairment; those taking monoamine oxidase inhibitors, reserpine, or tetrabenazine; and those who are suicidal or who have poorly controlled depression should not take deutetrabenazine.
- Teva announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease [news release]. http://www.tevapharm.com/news/teva_announces_fda_approval_of_austedo_deutetrabenazine_tablets_for_the_treatment_of_chorea_associated_with_huntington_s_disease_04_17.aspx. Published April 3, 2017. Accessed April 4, 2017.
- Frank S, Testa CM, Stamler D, et al; for the Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease. JAMA. 2016;316(1):40-50. doi: 10.1001/jama.2016.8655