Opakalim Medicine 04 December 2025 Extended indication Opakalim monotherapy for add-on treatment of refractory focal epilepsy in adults and elderly Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Opakalim Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Epilepsy Extended indication Opakalim monotherapy for add-on treatment of refractory focal epilepsy in adults and elderly Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biohaven Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks BHV-7000 is a novel, highly selective and potent activator of Kv7.2/Kv7.3 channels, key subunits involved in neuronal signaling and in regulating the hyperexcitable state in epilepsy. BHV-7000 was rationally developed as a potent activator of heteromeric Kv7.2/7.3 potassium channels, the molecular substrate that underlies the M-current (IKM). In addition, BHV-7000 does not exhibit GABAA receptor positive allosteric molecular activity, thereby reducing the potential for off-target effects. BHV-7000 is structurally distinct from other Kv7 activators, demonstrates potent anti-seizure effects and is well-tolerated in preclinical seizure models, and has shown potential to be a best-in-class Kv7 activator. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date April 2026 Expected Registration May 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Carbamazepine, lamotrigine, levetiracetam, oxcarbazepine en valproïnezuur. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit de fase 2/3 focal onset (RISE) zijn op dit moment nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 50mg of 75mg References NCT06132893 (RISE 2); NCT06309966 (RISE 3) Additional remarks Expected patient volume per year Patient volume 10,800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Volksgezondheidenzorg.info; CBS; Additional remarks De prevalentie van epilepsie die bekend was bij de huisarts in 2016 bedroeg 6,6 per 1.000 inwoners. In 2017 had Nederland 13,7 miljoen inwoners ouder dan 18 jaar. Dit betekent dat ongeveer 90.000 inwoners met epilepsie zijn gediagnosticeerd. Hiervan heeft ongeveer 60% focale aanval epilepsie (36.000), waarvan 30% refractair ziekte 10.800. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks