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]
 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 | |
| Pregnancy category |
|
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
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
editThe combination of foscarbidopa and foslevodopa is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.[5]
Side effects
editThe most common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.[5]
References
edit- ^ a b c "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.
- ^ a b "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.
- ^ a b "Regulatory Decision Summary for Vyalev". Health Canada. 3 May 2023. Retrieved 4 April 2024.
- ^ a b c d e f "Vyalev- foscarbidopa/foslevodopa injection". DailyMed. 16 October 2024. Retrieved 25 October 2024.
- ^ 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.
- ^ 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).
- ^ 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).
- ^ 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.
- ^ 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.
- ^ 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.
- ^ "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.
- ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf
- ^ "New Parkinson's drug Produodopa to be available on NHS". BBC News Online. 16 February 2024. Retrieved 12 October 2024.
- ^ "Video shows drug's 'life-changing' effect on man with Parkinson's". BBC News Online. Retrieved 12 October 2024.
 | This drug article relating to the nervous system is a stub. You can help Wikipedia by expanding it. |