Neridronic Acid

Active substance
Neridronic Acid
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Pain
Extended indication
Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy

1. Product

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.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. 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
Duration of treatment
Not found
Frequency of administration
4 times every 2 weeks
Dosage per administration
100 mg
References
NCT03560986, NCT03530345, NCT02972359
Additional comments
100 mg 4 maal in 10 dagen.

4. 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 leeftijdcategorie 61 tot 70 jaar. Meestal komt het voor aan 1 extremiteit maar CRPS is ook aan meerdere extremiteiten beschreven.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

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

Indication extension
No

9. Other information

There is currently no futher information available.