Foscarbidopa/foslevodopa explained

Type:combo
Component1:Foscarbidopa
Class1:Aromatic amino acid decarboxylation inhibitor
Component2:Foslevodopa
Class2:Aromatic amino acid
Tradename:Vyalev, others
Dailymedid:Foscarbidopa/foslevodopa
Pregnancy Au:B3
Routes Of Administration:Subcutaneous
Atc Prefix:N04
Atc Suffix:BA07
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2] [3] [4]
Legal Us:Rx-only
Legal Us Comment:[5]
Kegg:D12494
Synonyms:ABBV-951

Foscarbidopa/foslevodopa, sold under the brand name Vyalev among others, is a fixed-dose combination medication used for the treatment of Parkinson's disease. It is a fixed-dose combination of foscarbidopa, an aromatic amino acid decarboxylation inhibitor and prodrug for carbidopa; and foslevodopa, an aromatic amino acid and prodrug for levodopa that was developed by AbbVie.[6] [7] [8] [9] [10]

The combination was refused approval by the US Food and Drug Administration (FDA) in 2023.[11] It was approved for medical use in Canada in May 2023, in Australia in March 2024, and in the United States in October 2024.[12] [13]

Produodopa uses a pump to steadily release foscarbidopa/foslevodopa into the bloodstream round-the-clock. It is available via the UK National Health Service since February 2024.[14] [15]

Medical uses

The combination of foscarbidopa and foslevodopa is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Side effects

The most common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.

Notes and References

  1. Web site: Vyalev foslevodopa 2400 mg/10 mL and foscarbidopa 120 mg/10 mL solution for subcutaneous infusion vial (372902) . Therapeutic Goods Administration (TGA) . 28 March 2024 . 4 April 2024.
  2. Web site: Details for: Vyalev . . 5 February 2024 . 3 March 2024.
  3. Web site: Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23] ]. . 23 June 2023 . 3 January 2024.
  4. Web site: Regulatory Decision Summary for Vyalev . . 3 May 2023 . 4 April 2024.
  5. Web site: Vyalev- foscarbidopa/foslevodopa injection . DailyMed . 16 October 2024 . 25 October 2024.
  6. Rosebraugh . Matthew . Kym . Philip . Liu . Wei . Facheris . Maurizio . Benesh . Janet . A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson's Disease (P3.8-037) . Neurology . 9 April 2019 . 92 . 15 Supplement . 10.1212/WNL.92.15_supplement.P3.8-037 . 226858541 .
  7. Facheris . Maurizio . Criswell . Susan . Pavasia . Nirav . Pahwa . Rajesh . Locke . Charles . Robieson . Weining . Shprecher . David . Safety and Tolerability During a 4-Week Continuous Subcutaneous Infusion of ABBV-951, a New Drug Formulation for the Treatment of Parkinson's Disease: Final Results of a Phase 1b Study (1384) . Neurology . 14 April 2020 . 94 . 15 Supplement .
  8. Facheris . Maurizio . Benesh . Janet . Streit . Janet . Robieson . Weining . Zadikoff . Cindy . Standaert . David . Safety and Tolerability in Parkinson's Disease Patients Treated with a Continuous Subcutaneous Infusion of ABBV-951: Design of a 52-Week Phase 3 Study (4233) . Neurology . 14 April 2020 . 94 . 15 Supplement .
  9. Rosebraugh . Matthew . Kym . Philip . Liu . Wei . Facheris . Maurizio . ABBV-951 Maintains Stable Levodopa Exposure following Subcutaneous Infusion in Parkinson's Disease Patients (543) . Neurology . 14 April 2020 . 94 . 15 Supplement . 10.1212/WNL.94.15_supplement.543 . 266119262 .
  10. Facheris . Maurizio . Robieson . Weining . Fisseha . Nahome . Standaert . David . Efficacy and Safety of Foslevodopa/Foscarbidopa Versus Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients: Design of a Phase 3, Randomized, Double-Blind, Double-Dummy, Active Controlled 12-Week Trial (2251) . Neurology . 13 April 2021 . 96 . 15 Supplement . 10.1212/WNL.96.15_supplement.2251 . 266111372 .
  11. Web site: Liu . Angus . AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump . Fierce Pharma . 22 March 2023 . 4 April 2024.
  12. U.S. FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease . AbbVie . 17 October 2024 . 18 October 2024.
  13. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf
  14. News: 2024-02-16 . New Parkinson's drug Produodopa to be available on NHS . . 2024-10-12 .
  15. Web site: Video shows drug's 'life-changing' effect on man with Parkinson's . 2024-10-12 . .

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