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// Workers AI · dad joke modeWhat did Foscarbidopa/foslevodopa say? "I'm a compound interest.

From Wikipedia, the free encyclopedia
(Redirected from Vyalev)

Foscarbidopa/foslevodopa
Chemical structure of foscarbidopa
Chemical structure of foslevodopa
Combination of
FoscarbidopaAromatic amino acid decarboxylation inhibitor
FoslevodopaAromatic amino acid
Clinical data
Trade namesVyalev, others
Other namesABBV-951
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
KEGG

Foscarbidopa/foslevodopa, sold under the brand name Vyalev among others, is a fixed-dose combination medication used for the treatment of Parkinson's disease.[2][5] It is a fixed-dose combination of foscarbidopa, an aromatic amino acid decarboxylation inhibitor and prodrug for carbidopa;[5] and foslevodopa, an aromatic amino acid and prodrug for levodopa that was developed by AbbVie.[5][6][7][8][9][10] Its structure is identical to carbidopa/levodopa except for the replacement of a hydroxyl on each molecule with a phosphate group, similar to the antiepileptic prodrug fosphenytoin as it relates to phenytoin.[citation needed]

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,[4] in Australia in March 2024,[1] 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

[edit]

The combination of foscarbidopa and foslevodopa is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.[5]

Side effects

[edit]

The most common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.[5]

References

[edit]
  1. 1 2 3 "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. Retrieved 4 April 2024.
  2. 1 2 "Details for: Vyalev". Health Canada. 5 February 2024. Retrieved 3 March 2024.
  3. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23]". Health Canada. 23 June 2023. Retrieved 3 January 2024.
  4. 1 2 "Regulatory Decision Summary for Vyalev". Health Canada. 3 May 2023. Retrieved 4 April 2024.
  5. 1 2 3 4 5 6 "Vyalev- foscarbidopa/foslevodopa injection". DailyMed. 16 October 2024. Retrieved 25 October 2024.
  6. ↑ Rosebraugh, Matthew; Kym, Philip; Liu, Wei; Facheris, Maurizio; Benesh, Janet (9 April 2019). "A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson's Disease (P3.8-037)". Neurology. 92 (15 Supplement) P3.8-037. doi:10.1212/WNL.92.15_supplement.P3.8-037. S2CID 226858541.
  7. ↑ Facheris, Maurizio; Criswell, Susan; Pavasia, Nirav; Pahwa, Rajesh; Locke, Charles; Robieson, Weining; et al. (14 April 2020). "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. 94 (15 Supplement).
  8. ↑ Facheris, Maurizio; Benesh, Janet; Streit, Janet; Robieson, Weining; Zadikoff, Cindy; Standaert, David (14 April 2020). "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. 94 (15 Supplement).
  9. ↑ Rosebraugh, Matthew; Kym, Philip; Liu, Wei; Facheris, Maurizio (14 April 2020). "ABBV-951 Maintains Stable Levodopa Exposure following Subcutaneous Infusion in Parkinson's Disease Patients (543)". Neurology. 94 (15 Supplement) 543. doi:10.1212/WNL.94.15_supplement.543. S2CID 266119262.
  10. ↑ Facheris, Maurizio; Robieson, Weining; Fisseha, Nahome; Standaert, David (13 April 2021). "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. 96 (15 Supplement) 2251. doi:10.1212/WNL.96.15_supplement.2251. S2CID 266111372.
  11. ↑ Liu, Angus (22 March 2023). "AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump". Fierce Pharma. Retrieved 4 April 2024.
  12. ↑ "U.S. FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease". AbbVie (Press release). 17 October 2024. Retrieved 18 October 2024.
  13. ↑ fda.gov
  14. ↑ "New Parkinson's drug Produodopa to be available on NHS". BBC News Online. 16 February 2024. Retrieved 12 October 2024.
  15. ↑ "Video shows drug's 'life-changing' effect on man with Parkinson's". BBC News Online. 19 July 2024. Retrieved 12 October 2024.
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