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][7][8][9][10][11]
 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 |
| 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.[12] 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.[6][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 (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.[16]
Side effects
editThe most common adverse reactions are infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.[16]
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 https://www.rxabbvie.com/pdf/vyalev_pi.pdf
- ^ a b "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.
- ^ 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.
- ^ 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.
- ^ a b "HIGHLIGHTS OF PRESCRIBING INFORMATION" (PDF). RXABBIE). 20 October 2024. Retrieved 20 October 2024.
This article incorporates text from this source, which is in the public domain.
 | This drug article relating to the nervous system is a stub. You can help Wikipedia by expanding it. |