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.
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
The combination of foscarbidopa and foslevodopa is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.[5]
Side effects
The most common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.[5]
References
- 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^
- Details for: Vyalev Health Canada, 5 February 2024, retrieved 3 March 2024^
- Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23] Health Canada, 23 June 2023, retrieved 3 January 2024^
- Regulatory Decision Summary for Vyalev Health Canada, 3 May 2023, retrieved 4 April 2024^
- Vyalev- foscarbidopa/foslevodopa injection DailyMed, 16 October 2024, retrieved 25 October 2024^
- Matthew Rosebraugh, Philip Kym, Wei Liu, Maurizio Facheris, Janet Benesh. A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson's Disease (P3.8-037) Neurology, 9 April 2019^
- Maurizio Facheris, Susan Criswell, Nirav Pavasia, Rajesh Pahwa, Charles Locke, Weining Robieson, David Shprecher. 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^
- Maurizio Facheris, Janet Benesh, Janet Streit, Weining Robieson, Cindy Zadikoff, David Standaert. 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^
- Matthew Rosebraugh, Philip Kym, Wei Liu, Maurizio Facheris. ABBV-951 Maintains Stable Levodopa Exposure following Subcutaneous Infusion in Parkinson's Disease Patients (543) Neurology, 14 April 2020^
- Maurizio Facheris, Weining Robieson, Nahome Fisseha, David Standaert. 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^
- Angus Liu. AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump Fierce Pharma, 22 March 2023, retrieved 4 April 2024^
- U.S. FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease AbbVie, 17 October 2024, retrieved 18 October 2024^
- fda.gov^
- New Parkinson's drug Produodopa to be available on NHS BBC News Online, 2024-02-16, retrieved 2024-10-12^
- Video shows drug's 'life-changing' effect on man with Parkinson's BBC News Online, 19 July 2024, retrieved 2024-10-12^