page_banner

iindaba

Ngomhla wesi-2 ku-Matshi, i-US FDA ivume isicelo esitsha seziyobisi (i-NDA) se-AZSTARYS (igama lekhowudi: KP415), kanye ngemini, kunyango lwengxaki yokusilela kokuphazamiseka kwengqondo (ADHD) kwizigulana ezineminyaka emi-6 nangaphezulu. Iya kuthengiswa eMelika. Ukuya
I-AZSTARYS yifom yedosi ye-capsule yefomathi eyenziwe nge-dexmethylphenidate (d-MPH) yeprodrug serdexmethylphenidate (SDX) kunye nokukhululwa kwangoko d-MPH. I-AZSTARYS iqulethe i-30% yokukhululwa kwangoko kwe-d-MPH kunye ne-70% eyandisiweyo yokukhupha i-SDX entsha. Emva kokufunxwa kwiphecana lesisu, i-SDX iguqulwe yenziwa i-d-MPH, kwaye i-d-MPH ikhutshwa kancinci kungaphelanga usuku.图片2
Xa kuthelekiswa neziyobisi ezithengiswayo ngoku i-Vyvanse (Ridexamphetamine Dimesylate Capsules) kunye ne-Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), i-AZSTARYS inethuba lokuqala kwangoko ngenxa yokukhutshwa kwangoko kwe-d-MPH. Xa kuthelekiswa ne-Adderall XR (i-amphetamine complex salt-release-release capsules) kunye ne-Focalin XR (dexmethylphenidate hydrochloride-release-release capsules), kuba i-SDX yiprodrug, inokunciphisa ukuxhomekeka kwiziyobisi.
图片3
I-multicenter, i-blind-blind, i-randomized, i-placebo-elawulwa, isigaba se-III isifundo (i-NCT03292952) ivavanye ukusebenza kwe-AZSTARYS. Olu phando luye lwagaya abantwana abali-150 abaneminyaka emi-6 ukuya kweli-12 ubudala abane-ADHD. Iziphumo zophononongo zibonise ukuba xa kuthelekiswa neqela le-placebo, iimpawu zabantwana kwiqela le-AZSTARYS ziphuculwe kakhulu, kwaye amanqaku eSKAMP-C ancitshiswe ngomndilili wamanqaku ayi-5.4 xa kuthelekiswa neqela le-placebo.
图片4
Kuba i-AZSTARYS iqulethe i-d-MPH, eyi-Class II elawulwa yinto, i-FDA icebisa ukuba ii-AZSTARYS nazo zihlelwe ngokungqinelana nezinto ezilawulwayo zeklasi II. I-AZSTARYS iya kuthengiswa ngehlobo lowama-2021.


Ixesha Post: May-17-2021