Thaum Lub Peb Hlis 2, Asmeskas FDA tau pom zoo rau ib daim ntawv thov tshuaj tshiab (NDA) rau AZSTARYS (code code: KP415), ib hnub ib zaug, rau kev kho mob ntawm kev saib xyuas kev tsis txaus siab hyperactivity tsis meej (ADHD) hauv cov neeg mob 6 xyoo thiab laus dua. Yuav ua lag luam nyob Tebchaws Meskas. Rau
AZSTARYS yog cov tshuaj ntsiav tshuaj sib xyaw ua ke uas muaj dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) thiab kev tso tawm d-MPH. AZSTARYS muaj 30% tso tawm d-MPH thiab 70% txuas ntxiv tawm SDX tshiab. Tom qab tau tso dej raws txoj hnyuv, tus kab mob SDX tau hloov mus rau d-MPH, thiab d-MPH tau maj mam tawm hauv ib hnub.
Piv nrog rau cov tshuaj lag luam tam sim no Vyvanse (Ridexamphetamine Dimesylate Capsules) thiab Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS muaj qhov zoo ntawm qhov pib sai vim qhov tso tawm sai sai ntawm d-MPH. Piv nrog Adderall XR (amphetamine complex ntsev txhawb nqa-tsiav tshuaj) thiab Focalin XR (dexmethylphenidate hydrochloride txhawb-tso cov tshuaj ntsiav), vim tias SDX yog cov khoom tsim tawm, nws tuaj yeem txo kev quav yeeb tshuaj.
Cov neeg ua haujlwm ntau, ob qhov muag tsis pom kev, xaiv nkag, tshuaj placebo, kev kawm rau qib III (NCT03292952) ntsuas kev ua tau zoo ntawm AZSTARYS. Txoj kev tshawb no tau xaiv 150 cov menyuam yaus hnub nyoog 6-12 xyoo nrog rau kev kuaj mob ntawm ADHD. Cov txiaj ntsig ntawm txoj kev tshawb no pom tias piv nrog cov placebo pab pawg, cov tsos mob ntawm cov menyuam hauv pab pawg AZSTARYS tau zoo dua, thiab cov qhab nia SKAMP-C tau raug txo los ntawm qhov nruab nrab ntawm 5.4 cov qhab nia piv nrog pawg placebo.
Txij li AZSTARYS muaj d-MPH, uas yog Chav Kawm II tswj cov tshuaj, FDA tau pom zoo tias AZSTARYS tseem muab cais raws li Class II raug txwv. AZSTARYS yuav muag rau lub caij ntuj sov xyoo 2021.
Lub sij hawm tshaj tawm: Tsib Hlis-17-2021