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NgoMashi 2, i-US FDA ivume isicelo esisha sezidakamizwa (i-NDA) se-AZSTARYS (igama lekhodi: KP415), kanye ngosuku, ekwelapheni ukunakekelwa kokushoda kokungasebenzi (ADHD) ezigulini ezineminyaka engu-6 nangaphezulu. Izothengiswa e-United States. Ku
I-AZSTARYS iyifomu yesilinganiso se-capsule eyakhiwe i-dexmethylphenidate (d-MPH) i-prodrug serdexmethylphenidate (SDX) kanye nokukhishwa ngokushesha kwe-d-MPH. I-AZSTARYS iqukethe i-30% ekhishwa ngokushesha i-d-MPH ne-70% ekhishwe i-SDX entsha. Ngemuva kokumunca umgudu wamathumbu, i-SDX iguqulwa ibe yi-d-MPH, kuthi i-d-MPH ikhishwe kancane kancane phakathi nosuku.图片2
Uma kuqhathaniswa nezidakamizwa ezidayiswa njengamanje i-Vyvanse (Ridexamphetamine Dimesylate Capsules) kanye ne-Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), i-AZSTARYS inethuba lokuqala ngokushesha ngenxa yokukhishwa ngokushesha kwe-d-MPH. Uma kuqhathaniswa ne-Adderall XR (ama-amphetamine complex salt capsule-release capsule) kanye neFocalin XR (dexmethylphenidate hydrochloride capsule-release-release capsules), ngoba i-SDX iyisidakamizwa, inganciphisa ukuncika kwezidakamizwa.
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I-multicenter, blind-blind, randomized, elawulwa yi-placebo, isifundo sesigaba III (NCT03292952) ihlole ukusebenza kwe-AZSTARYS. Ucwaningo luqashe izingane eziyi-150 ezineminyaka engu-6-12 ngokutholakala kwe-ADHD. Imiphumela yocwaningo ikhombise ukuthi uma kuqhathaniswa neqembu le-placebo, izimpawu zezingane eziseqenjini le-AZSTARYS zithuthukiswe kakhulu, futhi amaphuzu e-SKAMP-C ancishiswe ngamaphuzu aphakathi kuka-5.4 uma kuqhathaniswa neqembu le-placebo.
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Njengoba i-AZSTARYS iqukethe i-d-MPH, okuyi-Class II elawulwa into, i-FDA incoma ukuthi i-AZSTARYS nayo ihlukaniswe ngokuhambisana nezinto ezilawulwa yi-Class II. I-AZSTARYS izothengiswa ehlobo lika-2021.


Isikhathi Iposi: May-17-2021