Chemical compound
Pharmaceutical compound
Deutetrabenazine (trade nameAustedo ) is avesicular monoamine transporter 2 inhibitor which is used for the treatment ofchorea associated withHuntington's disease andtardive dyskinesia .
Chemically, deutetrabenazine is anisotopic isomer oftetrabenazine in which six hydrogen atoms have been replaced bydeuterium atoms. The incorporation of deuterium slows the rate ofdrug metabolism , allowing less frequent dosing.[ 5] [ 6]
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]
Deutetrabenazine acts as amonoamine-depleting agent .[ 8]
Teva Pharmaceuticals received approval from theFood and Drug Administration to market deutetrabenazine in early 2017, along with five years oforphan drug exclusivity for the treatment of chorea associated with Huntington's disease. It was the firstdeuterated drug to receive FDA approval.[ 9] [ 10] [ 11]
^a b "Austedo" .Therapeutic Goods Administration (TGA) . 9 June 2021.Archived from the original on 6 September 2021. Retrieved6 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 . Retrieved22 October 2023 .^ "AusPAR: Deutetrabenazine" .Therapeutic Goods Administration (TGA) . 27 May 2022.Archived from the original on 27 May 2022. Retrieved13 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. Retrieved16 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. Retrieved4 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. Retrieved4 February 2018 . ^ "Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors" .LiverTox: Clinical and Research Information on Drug-Induced Liver Injury . National Institute of Diabetes and Digestive and Kidney Diseases. 2012.^ "FDA Approves Drug for Huntington's Disease" . 3 April 2017.Archived from the original on 23 January 2019. Retrieved4 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. Retrieved5 November 2017 .
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