Levodopa

Active substance
Levodopa
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Parkinson's
Extended indication
Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

1. Product

Proprietary name
Inbrija
Manufacturer
Acorda
Mechanism of action
Neurotransmitter
Route of administration
Inhalation
Therapeutical formulation
Oral powder
Budgetting framework
Extramural (GVS)
Additional comments
Precursor van dopamine.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
June 2018
Expected Registration
September 2019
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Nieuws september 2018: "Acorda Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has extended its decision date on inhaled levodopa to January 5, 2019. According to a press release, the extension is related to submission of additional information on the drug’s chemistry and manufacturing that will take additional time for the FDA to review. "

3. Therapeutic value

Current treatment options
Andere formuleringen van levodopa
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
5 times a day
References
NCT02240030
Additional comments
SPAN-PD trial met primary endpoint: CVT-301 showed statistically significant improvement of motor function compared to placebo. In deze studie is het effect niet vergeleken met Sinemet.

4. Expected patient volume per year

References
GIPdatabank
Additional comments
In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Afhankelijk van de meerwaarde zal Inbrija hier een deel van overnemen.

5. Expected cost per patient per year

Cost
800 - 900
References
GIPdatabank
Additional comments
In 2016 werd er €859,70 per gebruiker van Sinemet vergoed.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.