Levodopa Inbrija Active substance LevodopaDomain Neurological disordersReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Parkinson'sExtended indication Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. 1. Product Proprietary name InbrijaManufacturer AcordaMechanism of action NeurotransmitterRoute of administration InhalationTherapeutical formulation Oral powderBudgetting framework Extramural (GVS)Additional comments Precursor van dopamine. 2. Registration Registration route Centralised (EMA)Type of trajectory Normal trajectoryParticularity New therapeutical formulationSubmission date June 2018Expected Registration September 2019Orphan drug NoRegistration phase Registration application pendingAdditional 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 levodopaTherapeutic value No judgementDuration of treatment Not foundFrequency of administration 5 times a dayReferences NCT02240030Additional 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 GIPdatabankAdditional 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 - € 900References GIPdatabankAdditional 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.