|Other names||Tetrabenazine D6; SD809; SD-809|
|Drug class||Vesicular monoamine transporter 2 (VMAT2) inhibitor|
|Main uses||Huntington’s disease, tardive dyskinesia, Tourette's syndrome|
|Side effects||Sleepiness, diarrhea, dry mouth, trouble sleeping|
|Chemical and physical data|
|Molar mass||323.462 g·mol−1|
Deutetrabenazine, sold under the brand name Austedo, is a medication used to treat Huntington’s disease associated chorea, tardive dyskinesia, and Tourette's syndrome. It is taken by mouth twice per day.
Common side effects include sleepiness, diarrhea, dry mouth, and trouble sleeping. Other side effects may include QT prolongation, neuroleptic malignant syndrome, and parkinsonism. It should not be used in people with liver problems or who are suicidal. It is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Deutetrabenazine was approved for medical use in the United States in 2017. In the United States 60 tablets of 12 mg costs about 6,000 USD as of 2021. It is similar to tetrabenazine except it contains deuterium.
A study published in 2017 where 298 people were randomly assigned to receive at least one of the following: one dose of placebo per day, one dose of deutetrabenazine 12 mg/day, one dose of deutetrabenazine 24 mg/day, or one dose of deutetrabenazine 36 mg/day. From baseline to week 12, the least-squares mean AIMS (Abnormal Involuntary Movement Scale) score improved by −3.3 points in the deutetrabenazine 36 mg/day group, −3.2 points in the 24 mg/day group, −2.1 points in the 12 mg/day group, and −1.4 points in the placebo group. Deutetrabenazine 24 mg/day and 36 mg/day provided a significant reduction in tardive dyskinesia, with favourable safety and tolerability. These findings suggest that dosing could be individualized on the basis of dyskinesia control and tolerability.
It is generally taken at a dose of 6 to 48 mg/day.
Chemically, deutetrabenazine is an isotopic isomer of tetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms. The incorporation of deuterium slows the rate of drug metabolism, allowing less frequent dosing.
Teva Pharmaceuticals received approval from the Food and Drug Administration to market deutetrabenazine in early 2017, along with five years of orphan drug exclusivity for the treatment of chorea associated with Huntington's disease. It was the first deuterated drug to receive FDA approval.
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- Anderson, Karen E; Stamler, David; Davis, Mat D; Factor, Stewart A; Hauser, Robert A; Isojärvi, Jouko; Fredrik L, Jarskog; Jimenez-Shahed, Joohi; Kumar, Rajeev; McEvoy, Joseph P; Ochudlo, Stanislaw; Ondo, William G; Fernandez, Hubert H (June 28, 2017). "Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial". The Lancet. 4 (8): 595–604. doi:10.1016/S2215-0366(17)30236-5. PMID 28668671. Retrieved February 4, 2018.
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- "FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions". FDA Law Blog. 16 July 2017. Retrieved 5 November 2017.
- Dean L (May 2019). "Deutetrabenazine Therapy and CYP2D6 Genotype". In Pratt VM, McLeod HL, Rubinstein WS, et al. (eds.). Medical Genetics Summaries. National Center for Biotechnology Information (NCBI). PMID 31046213.