Jump to content

Main menu Navigation ●Main page ●Contents ●Current events ●Random article ●About Wikipedia ●Contact us ●Donate Contribute ●Help ●Learn to edit ●Community portal ●Recent changes ●Upload file

●Create account ●Log in ●Create account ● Log in Pages for logged out editors learn more ●Contributions ●Talk

(Top) 1 Efficacy 2 Pharmacology 2.1 Pharmacodynamics 3 History 4 See also 5 References 6 Further reading 7 External links

Deutetrabenazine

●العربية ●ଓଡ଼ିଆ Edit links ●Article ●Talk ●Read ●Edit ●View history Tools Actions ●Read ●Edit ●View history General ●What links here ●Related changes ●Upload file ●Special pages ●Permanent link ●Page information ●Cite this page ●Get shortened URL ●Download QR code ●Wikidata item Print/export ●Download as PDF ●Printable version Appearance From Wikipedia, the free encyclopedia

Deutetrabenazine
Clinical data

Trade names	Austedo
Other names	Tetrabenazine D6; SD809; SD-809
AHFS/Drugs.com	Monograph
MedlinePlus	a617022
License data	US DailyMed: Deutetrabenazine
Pregnancy category	AU: B3^[1]
Routes of administration	By mouth
ATC code	N07XX16 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)^[1]^[3] BR: Class C1 (Other controlled substances)^[4] US: WARNING^[2]Rx-only
Identifiers
IUPAC name (3R,11bR)-3-(2-Methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one
CAS Number	1392826-25-3
PubChem CID	73437646
DrugBank	DB12161
ChemSpider	34222717
UNII	P341G6W9NB
KEGG	D10701
Chemical and physical data
Formula	C₁₉H₂₁D₆NO₃
Molar mass	323.462 g·mol⁻¹

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Chemically, deutetrabenazine is an isotopic isomeroftetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms.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.^[5]^[6]

Efficacy[edit]

ALancet 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.^[7]

Pharmacology[edit]

Pharmacodynamics[edit]

Deutetrabenazine acts as a monoamine-depleting agent.^{[citation needed]}

History[edit]

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.^[8]^[9]^[10]

References[edit]

^ ^a ^b "Austedo". Therapeutic Goods Administration (TGA). 9 June 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.

^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.

^ "AusPAR: Deutetrabenazine". Therapeutic Goods Administration (TGA). 27 May 2022. Archived from the original on 27 May 2022. Retrieved 13 June 2022.

^ Anvisa (31 March 2023). "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] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.

^ Citrome L (April 2016). "Breakthrough drugs for the interface between psychiatry and neurology". International Journal of Clinical Practice. 70 (4): 298–299. doi:10.1111/ijcp.12805. PMID 27028671. Archived from the original on 21 August 2020. Retrieved 4 April 2017.

^ Coppen EM, Roos RA (January 2017). "Current Pharmacological Approaches to Reduce Chorea in Huntington's Disease". Drugs. 77 (1): 29–46. doi:10.1007/s40265-016-0670-4. PMC 5216093. PMID 27988871.

^ Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojärvi J, et al. (August 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. Psychiatry. 4 (8): 595–604. doi:10.1016/S2215-0366(17)30236-5. PMID 28668671. Archived from the original on 28 August 2021. Retrieved 4 February 2018.

^ "FDA Approves Drug for Huntington's Disease". 3 April 2017. Archived from the original on 23 January 2019. Retrieved 4 April 2017.

^ Schmidt C (June 2017). "First deuterated drug approved". Nature Biotechnology. 35 (6): 493–494. doi:10.1038/nbt0617-493. PMID 28591114. S2CID 205269152.

^ "FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions". FDA Law Blog. 16 July 2017. Archived from the original on 7 November 2017. Retrieved 5 November 2017.