Cyclobenzaprine hydrochloride Medicine 07 December 2021 Extended indication Patients With Fibromyalgia Therapeutic value No estimate possible yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Tonix Pharmaceuticals Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Sublingual tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Alpha 1 adrenergic receptor antagonist; Histamine H1 receptor antagonist; Serotonin 2A receptor antagonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04172831(RELIEF) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. Additional remarks 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Post-traumatic stress disorders References Adisinsight Additional remarks Lopende fase 3 studie. Other information Additional remarks