Deutetrabenazine Explained

Tradename:	Austedo
Dailymedid:	Deutetrabenazine
Pregnancy Au:	B3
Routes Of Administration:	By mouth
Atc Prefix:	N07
Atc Suffix:	XX16
Legal Au:	S4
Legal Au Comment:	^[1] ^[2]
Legal Br:	C1
Legal Br Comment:	^[3]
Legal Us:	Rx-only
Cas Number:	1392826-25-3
Pubchem:	73437646
Drugbank:	DB12161
Chemspiderid:	34222717
Unii:	P341G6W9NB
Kegg:	D10701
Synonyms:	Tetrabenazine D6; SD809; SD-809
Iupac Name:	(3R,11bR)-3-(2-Methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[''a'']quinolizin-2-one
C:	19
H:	21
D:	6
N:	1
O:	3

Deutetrabenazine (trade name Austedo) is a vesicular monoamine transporter 2 inhibitor which is used for the treatment of chorea associated with Huntington's disease and tardive dyskinesia.

Chemically, deutetrabenazine is an isotopic isomer of tetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms.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.^{[4] [5]}

Efficacy

A Lancet study published on 28 June 2017 carried out a review between 29 October 2014 and 19 August 2016 where 298 patients 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 regimens could be individualized and tailored for patients on the basis of dyskinesia control and tolerability.^[6]

Pharmacology

Pharmacodynamics

Deutetrabenazine acts as a monoamine-depleting agent.

History

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.^{[7] [8] [9]}

See also

• Tetrabenazine
• Valbenazine

Further reading

• Book: Medical Genetics Summaries . Deutetrabenazine Therapy and CYP2D6 Genotype . https://www.ncbi.nlm.nih.gov/books/NBK540716/ . Pratt VM, McLeod HL, Rubinstein WS, Scott SA, Dean LC, Kattman BL, Malheiro AJ . 3 . National Center for Biotechnology Information (NCBI) . May 2019 . 31046213 . Dean L .

External links

• Web site: Deutetrabenazine . U.S. National Library of Medicine . Drug Information Portal .

Notes and References

1. Web site: Austedo . Therapeutic Goods Administration (TGA) . 9 June 2021 . 6 September 2021 . 6 September 2021 . https://web.archive.org/web/20210906212351/https://www.tga.gov.au/apm-summary/austedo . live .
2. Web site: AusPAR: Deutetrabenazine . Therapeutic Goods Administration (TGA) . 27 May 2022 . 13 June 2022 . 27 May 2022 . https://web.archive.org/web/20220527012427/https://www.tga.gov.au/auspar/auspar-deutetrabenazine . live .
3. Web site: Anvisa . Brazilian Health Regulatory Agency . 2023-03-31 . RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial . Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control. live . https://web.archive.org/web/20230803143925/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 . 2023-08-03 . 2023-08-16 . . pt-BR . 2023-04-04.
4. Citrome L . Breakthrough drugs for the interface between psychiatry and neurology . International Journal of Clinical Practice . 70 . 4 . 298–299 . April 2016 . 27028671 . 10.1111/ijcp.12805 . 4 April 2017 . live . free . https://web.archive.org/web/20200821171732/https://www.medscape.com/viewarticle/861499 . 21 August 2020 .
5. Coppen EM, Roos RA . Current Pharmacological Approaches to Reduce Chorea in Huntington's Disease . Drugs . 77 . 1 . 29–46 . January 2017 . 27988871 . 5216093 . 10.1007/s40265-016-0670-4 .
6. Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojärvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH . 6 . Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial . The Lancet. Psychiatry . 4 . 8 . 595–604 . August 2017 . 28668671 . 10.1016/S2215-0366(17)30236-5 . 4 February 2018 . live . https://web.archive.org/web/20210828060015/https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366%2817%2930236-5/fulltext . 28 August 2021 .
7. Web site: FDA Approves Drug for Huntington's Disease . 3 April 2017 . 4 April 2017 . 23 January 2019 . https://web.archive.org/web/20190123211235/https://www.raredr.com/news/fda-approves-drug-for-huntingtons-chorea . live .
8. Schmidt C . First deuterated drug approved . Nature Biotechnology . 35 . 6 . 493–494 . June 2017 . 28591114 . 10.1038/nbt0617-493 . 205269152 .
9. Web site: FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions. FDA Law Blog. 16 July 2017. 5 November 2017. 7 November 2017. https://web.archive.org/web/20171107011037/http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/07/fda-determines-that-deuterated-compounds-are-nces-and-different-orphan-drugs-versus-non-deuterated-v.html. live.