Amantadine

Active substance Amantadine
Domain Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Parkinson's
Extended indication Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease

Product

Proprietary name Gocovri
Manufacturer Adamas
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 137-274 mg
References Prescribing information Gocovri, FDA

Expected patient volume per year

References Eusebi et al. NPJ Parkinsons Dis. 2018; 4: 33.
Additional comments In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Ongeveer een kwart van de patiënten krijgt last van levodopa-induced dyskiesia (8.981 patiënten). Hoeveel patiënten hiervan zullen worden behandeld met Gocovri hangt af van de uiteindelijke indicatie en plek in de behandelrichtlijn.

Expected cost per patient per year

References https://seekingalpha.com/article/4108394-adamas-releases-pricing-gocovri
Additional comments De lijstprijs in de Verenigde Staten is $28.500 per jaar (~€25.500). In de Europa zal dit waarschijnlijk lager geprijsd worden.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Multiple Sclerosis Patients With Walking Impairment
References Clinicaltrials.gov

Other information

There is currently no futher information available.