Adezunap Medicine 03 June 2025 Extended indication Adezunap monotherapy for add-on treatment of moderate to severe Chronic (back) pain in adults and elderly due to traumatic or post-operative peripheral neuropathy, central neuropathy of any genesis or due to diabetic polyneuropathy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Adezunap Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Adezunap monotherapy for add-on treatment of moderate to severe Chronic (back) pain in adults and elderly due to traumatic or post-operative peripheral neuropathy, central neuropathy of any genesis or due to diabetic polyneuropathy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Apurano Portfolio holder Mechanism of action Unknown Route of administration Sublingual Therapeutical formulation Spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 1,1 mg References NCT06071936; NCT06071949; NCT06071975; NCT06071962 Additional remarks Sublinguale spray met maximale toepassing van 16 pufjes per dag of een maximale dagelijkse dosis van 17,6mg THC verdeeld over 4 innamen. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks