Extended indication Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Neridronic Acid
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Pain
Extended indication Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy
Manufacturer Abiogen
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Potent osteoclast inhibitor - reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme. Fabrikant: Abiogen Pharma.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Anti-inflammatoire therapieën (zoals dimethyl sulfoxide and N-acetylcysteine, biphosphonaten zoals clodronate en aledronate en corticosteroïden), farmacologische analgetische therapieën (zoals ketamine intraveneus, gabapentine), vasodilatoire therapie (calcium influx blokkade, ketanserine), spasmolytische therapie (orale spasmolytische therapie met benzodiazepines of baclofen, baclofen intrathecaal bij patiënten met bijkomende dyskinesie). (Universitair Pijn Centrum Maastricht (UPCM))
Therapeutic value No estimate possible yet
Frequency of administration 4 times every 2 weeks
Dosage per administration 100 mg
References NCT03560986, NCT03530345, NCT02972359
Additional comments 100mg 4 maal in 10 dagen.

Expected patient volume per year

Patient volume

< 5,000

Market share is generally not included unless otherwise stated.

References SPS, Universitair Pijn Centrum Maastricht (UPCM)
Additional comments SPS: "Incidence rates of Complex Regional Pain Syndrome (CRPS) are around 26 per 100,000 patient years in Europe. CRPS has a mean age of onset of 46 years." Universitair Pijn Centrum Maastricht (UPCM): De incidentie van CRPS is 26,2 per 100.000 persoonsjaren en komt vaker voor in de bovenste extremiteit. Een fractuur is de meest voorkomende initiërende gebeurtenis. Vrouwen krijgen 3,4 x vaker CRPS dan mannen. De hoogste incidentie wordt vastgesteld bij vrouwen in de leeftijdscategorie 61 tot 70 jaar. Meestal komt het voor aan 1 extremiteit maar CRPS is ook aan meerdere extremiteiten beschreven.

Expected cost per patient per year

References Drugs.com
Additional comments In de Verenigde Staten een prijs van $49.40 4mg/100ml. 100mg 4 maal in 10 dagen. $197,60 = €163,15. De definitieve prijs in Nederland is nog niet bekend.

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 No

Other information

There is currently no futher information available.