Deutetrabenazine

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Deutetrabenazine
Deutetrabenazine.svg
Names
Trade namesAustedo
Other namesTetrabenazine D6; SD809; SD-809
  • (3R,11bR)-3-(2-Methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one
Clinical data
Drug classVesicular monoamine transporter 2 (VMAT2) inhibitor[1]
Main usesHuntington’s disease, tardive dyskinesia, Tourette's syndrome[1]
Side effectsSleepiness, diarrhea, dry mouth, trouble sleeping[2]
Routes of
use
By mouth
External links
AHFS/Drugs.comMonograph
US NLMDeutetrabenazine
MedlinePlusa617022
Legal
License data
Legal status
Chemical and physical data
FormulaC19H21D6NO3
Molar mass323.462 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.[1] It is taken by mouth twice per day.[1]

Common side effects include sleepiness, diarrhea, dry mouth, and trouble sleeping.[2] Other side effects may include QT prolongation, neuroleptic malignant syndrome, and parkinsonism.[2] It should not be used in people with liver problems or who are suicidal.[2] It is a vesicular monoamine transporter 2 (VMAT2) inhibitor.[1]

Deutetrabenazine was approved for medical use in the United States in 2017.[1] In the United States 60 tablets of 12 mg costs about 6,000 USD as of 2021.[3] It is similar to tetrabenazine except it contains deuterium.[1]

Medical uses

Efficacy

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.[4]

Dosage

It is generally taken at a dose of 6 to 48 mg/day.[2]

Chemistry

Chemically, deutetrabenazine is an isotopic isomer of tetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms.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

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]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Deutetrabenazine Monograph for Professionals". Drugs.com. Retrieved 23 December 2021.
  2. 2.0 2.1 2.2 2.3 2.4 "DailyMed - AUSTEDO- deutetrabenazine tablet, coated AUSTEDO- deutetrabenazine kit". dailymed.nlm.nih.gov. Retrieved 23 December 2021.
  3. "Deutetrabenazine Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 23 December 2021.
  4. 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.
  5. Citrome L (April 2016). "Breakthrough Drugs for the Interface Between Psychiatry and Neurology". International Journal of Clinical Practice. 70 (4): 298–9. doi:10.1111/ijcp.12805. PMID 27028671.
  6. 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.
  7. "FDA Approves Drug for Huntington's Disease". April 3, 2017.
  8. Schmidt, C (7 June 2017). "First deuterated drug approved". Nature Biotechnology. 35 (6): 493–494. doi:10.1038/nbt0617-493. PMID 28591114. S2CID 205269152.
  9. "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.

External links

External sites:
Identifiers: