Foscarbidopa/foslevodopa, sold under the brand name Vyalev among others, is a
fixed-dose combination
A combination drug is a combination of two or more pharmaceutical drugs as active ingredients combined into a single dosage form, typically as a ''fixed-dose combination'', with each constituent standardized to specifications of a fixed dose. Fix ...
medication used for the treatment of
Parkinson's disease
Parkinson's disease (PD), or simply Parkinson's, is a neurodegenerative disease primarily of the central nervous system, affecting both motor system, motor and non-motor systems. Symptoms typically develop gradually and non-motor issues become ...
.
It is a fixed-dose combination of
foscarbidopa, an
aromatic amino acid decarboxylation inhibitor and
prodrug
A prodrug is a pharmacologically inactive medication or compound that, after intake, is metabolized (i.e., converted within the body) into a pharmacologically active drug. Instead of administering a drug directly, a corresponding prodrug can be ...
for
carbidopa
Carbidopa, sold under the brand name Lodosyn, is a medication given to people with Parkinson's disease in order to inhibit peripheral metabolism of levodopa. This property is significant in that it allows a greater proportion of administered levo ...
;
and
foslevodopa
Foslevodopa is a medication which acts as a prodrug for levodopa, originally invented in the 1980s but not developed for medical use at that time. It is approved for use in a subcutaneous infusion as a fixed-dose combination with foscarbidopa ...
, an
aromatic amino acid
An aromatic amino acid is an amino acid that includes an aromaticity, aromatic ring.
Among the 20 standard amino acids, histidine, phenylalanine, tryptophan, tyrosine, are classified as aromatic.
Properties and function Optical properties
Ar ...
and prodrug for
levodopa
Levodopa, also known as L-DOPA and sold under many brand names, is a dopaminergic medication which is used in the treatment of Parkinson's disease (PD) and certain other conditions like dopamine-responsive dystonia and restless legs syndrome. ...
that was developed by
AbbVie
AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is ranked sixth on the list of largest biomedical companies by revenue. In 2023, the company's seat in Forbes Global 2000 was 74, and rank 89 on the ...
.
Its structure is identical to
carbidopa
Carbidopa, sold under the brand name Lodosyn, is a medication given to people with Parkinson's disease in order to inhibit peripheral metabolism of levodopa. This property is significant in that it allows a greater proportion of administered levo ...
/
levodopa
Levodopa, also known as L-DOPA and sold under many brand names, is a dopaminergic medication which is used in the treatment of Parkinson's disease (PD) and certain other conditions like dopamine-responsive dystonia and restless legs syndrome. ...
except for the replacement of a
hydroxyl
In chemistry, a hydroxy or hydroxyl group is a functional group with the chemical formula and composed of one oxygen atom covalently bonded to one hydrogen atom. In organic chemistry, alcohols and carboxylic acids contain one or more hydroxy ...
on each
molecule
A molecule is a group of two or more atoms that are held together by Force, attractive forces known as chemical bonds; depending on context, the term may or may not include ions that satisfy this criterion. In quantum physics, organic chemi ...
with a
phosphate
Phosphates are the naturally occurring form of the element phosphorus.
In chemistry, a phosphate is an anion, salt, functional group or ester derived from a phosphoric acid. It most commonly means orthophosphate, a derivative of orthop ...
group, similar to the antiepileptic prodrug
fosphenytoin
Fosphenytoin, also known as fosphenytoin sodium, and sold under the brand name Cerebyx among others, is a water-soluble phenytoin prodrug that is administered intravenously to deliver phenytoin, potentially more safely than intravenous phenytoi ...
as it relates to
phenytoin
Phenytoin (PHT), sold under the brand name Dilantin among others, is an anticonvulsant, anti-seizure medication. It is useful for the prevention of tonic-clonic seizures (also known as grand mal seizures) and focal seizures, but not absence se ...
.
The combination was refused approval by the US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(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
The National Health Service (NHS) is the term for the publicly funded health care, publicly funded healthcare systems of the United Kingdom: the National Health Service (England), NHS Scotland, NHS Wales, and Health and Social Care (Northern ...
since February 2024.
Medical uses
The combination of foscarbidopa and foslevodopa is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
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
{{Authority control
Aromatic L-amino acid decarboxylase inhibitors
Antiparkinsonian agents
Combination drugs
Dopamine agonists
Drugs developed by AbbVie
Monoamine precursors
Prodrugs