Extended indication Patients With Fibromyalgia
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Cyclobenzaprine hydrochloride
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Rheumatism
Extended indication Patients With Fibromyalgia
Manufacturer Tonix Pharmaceuticals
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Sublingual tablet
Budgetting framework Extramural (GVS)
Additional comments Alpha 1 adrenergic receptor antagonist; Histamine H1 receptor antagonist; Serotonin 2A receptor antagonist.

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Pirmary completion datum in oktober 2020.

Therapeutic value

Current treatment options Er zijn geen medicijnen om de aandoening te genezen. Wel kunnen de klachten verminderen met pijnstillers, regelmatige beweging en gedoseerde rust.
Therapeutic value No estimate possible yet
References NCT04172831(RELIEF)

Expected patient volume per year

References Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55.
Additional comments De prevalentie van fibromyalgie, gedefinieerd als pijn verspreid over het lichaam, vaak samengaand met moeheid, geheugenproblemen en slaapstoornissen, wordt geschat op 2-8% van de algemene bevolking.

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 Yes
Indication extensions Post-traumatic stress disorders
References Adisinsight
Additional comments Lopende fase 3 studie.

Other information

There is currently no futher information available.