Ecopipam Medicine 03 June 2025 Extended indication Ecopipam monotherapy for treatment of Touretteʼs syndrome in children over 6 years of age, adolescents, adults and elderly with both motor and vocal tics. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ecopipam Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Ecopipam monotherapy for treatment of Touretteʼs syndrome in children over 6 years of age, adolescents, adults and elderly with both motor and vocal tics. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Emalex Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Ecopipam blokkeert dopamine alleen op D1-receptoren. In dit complexe systeem moduleert dopamine de motorische controle, evenals gedragsimpulsiviteit, beloningsvalentie en leren, via de D2-achtige receptoren en de D1-achtige receptoren. Ecopipam, een selectieve D1r antagonist, zou een klinisch betekenisvolle vermindering van tics kunnen bereiken zonder de nadelen van D2r antagonisten. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Bij de behandeling van het Tourette syndroom spelen antipsychotica zoals haloperidol en pimozide een belangrijke rol om de tics te onderdrukken. De werking van deze antipsychotica (of neuroleptica) berust op het blokkeren van de dopamine-D2 receptoren. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 1,8 mg/kg References NCT05615220 (D1AMOND) Additional remarks 1,8mg/kg/day ecopipam (2mg/kg/day ecopipam HCl) daily Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 1,200.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Additional remarks Kosten op basis van IHSI-inschatting, gebaseerd op de prijs van het placeholder-medicijn aripiprazole van €1.133,29 per patiënt per jaar in Nederland. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks