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Musi waKurume 2, iyo US FDA yakabvumidza chishandiso chitsva chemushonga (NDA) cheAZSTARYS (kodhi zita: KP415), kamwe pazuva, kuitira kurapwa kwekucherechedza kushomeka kwehutano hwehutachiona (ADHD) mune varwere vane makore matanhatu zvichikwira. Tichave nekutengesa muUnited States. Ku
AZSTARYS iri remubatanidzwa capsule muyero fomu rinoumbwa ne dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) uye nekukurumidza kusunungurwa d-MPH. AZSTARYS ine 30% nekukurumidza kusunungurwa d-MPH uye 70% yakawedzerwa kuburitsa itsva SDX. Mushure mekunyudzwa kuburikidza nemudumbu wemudumbu, SDX inoshandurwa kuita d-MPH, uye d-MPH inosunungurwa zvishoma nezvishoma mukati mezuva.图片2
Zvichienzaniswa nemishonga irikutengeswa parizvino Vyvanse (Ridexamphetamine Dimesylate Capsules) uye Osmotic (Methylphenidate Hydrochloride Sustained Release Mahwendefa), AZSTARYS ine mukana wekutanga nekukurumidza nekuda kwekuburitswa d-MPH. Inofananidzwa neAdderall XR (amphetamine yakaoma munyu yakasimbiswa-kuburitsa makapisi) uye Focalin XR (dexmethylphenidate hydrochloride inosimudzira-kuburitsa makapisi), nekuti SDX iri prodrug, inogona kudzora kutsamira kwezvinodhaka.
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A multicenter, maviri-bofu, akasarudzika, placebo-inodzorwa, chikamu III kudzidza (NCT03292952) yakaongorora kushanda kweAZSTARYS. Chidzidzo chakatora vana zana nemakumi mashanu vane makore matanhatu kusvika matanhatu ekubatwa nechirwere cheADHD. Mhedzisiro yeongororo yakaratidza kuti zvichienzaniswa neboka re placebo, zviratidzo zvevana muboka reAZSTARYS zvakagadziridzwa zvakanyanya, uye mamaki eSKAMP-C akaderedzwa neavhareji e5,4 mapoinzi achienzaniswa neboka re placebo.
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Sezvo AZSTARYS iine d-MPH, inova Kirasi II inodzorwa zvinhu, iyo FDA inokurudzira kuti AZSTARYS iverengerwe zvinoenderana neClass II inodzorwa zvinhu. AZSTARYS ichatanga kutengeswa muzhizha ra2021.


Post nguva: Chivabvu-17-2021