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Foscarbidopa/foslevodopa

Chemical structure of foscarbidopa
Chemical structure of foslevodopa
Combination of
Foscarbidopa	Aromatic amino acid decarboxylation inhibitor
Foslevodopa	Aromatic amino acid
Clinical data
Trade names	Vyalev, others
Other names	ABBV-951
License data	US DailyMed: Foscarbidopa/foslevodopa
Pregnancy category	AU: B3
Routes of administration	Subcutaneous
ATC code	N04BA07 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only US: ℞-only
Identifiers
KEGG	D12494

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. 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.

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

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.

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.

References

1. ^ "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. ^ "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. ^ "Regulatory Decision Summary for Vyalev". Health Canada. 3 May 2023. Retrieved 4 April 2024.
5. ^ "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). 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). 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). 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. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf
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. Retrieved 12 October 2024.

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