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Neridronic Acid

Extended indication Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy
Therapeutic value No judgement
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 Grunenthal
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Potent osteoclast inhibitor - reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug Yes
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 iv, gabapentine), vasodilatoire therapie (calcium influx blokkade, ketanserine), spasmolytische therapie (orale spasmolytische therapie met benzodiazepines of baclofen, baclofen intrathecaal bij patiënten met bijkomende diskinesie). (Universitair Pijn Centrum Maastricht (UPCM))
Therapeutic value No judgement
Frequency of administration 4 times every 2 weeks
Dosage per administration 100 mg
References NCT03560986, NCT03530345, NCT02972359
Additional remarks 100 mg 4 maal in 10 dagen.

Expected patient volume per year

References SPS, Universitair Pijn Centrum Maastricht (UPCM)
Additional remarks 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 leeftijdcategorie 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

There is currently nothing known about the expected cost.

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.