tala fou

I le masina o Mati 2, ua faʻamaonia ai e le US FDA se talosaga fou mo fualaʻau (NDA) mo le AZSTARYS (code name: KP415), e tasi i le aso, mo le togafitia o le faʻafitauli o le le atoatoa o le hyperactivity (ADHD) i tagata mamaʻi 6 tausaga ma luga atu. O le a faʻapisinisi i le Iunaite Setete. Ia
AZSTARYS o se vailaʻau o vailaʻau o vailaʻau e aofia ai le dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) ma le faʻasaʻolotoina d-MPH. AZSTARYS o loʻo iai le 30% faʻamalolo loa d-MPH ma le 70% faʻalauteleina faʻamalolo fou SDX. A maeʻa ona mitiia e ala i le gastrointestinal tract, ua suia le SDX i le d-MPH, ma o le d-MPH e faʻasolosolo malie ona faʻamalolo i totonu o le aso.
Faʻatusatusa i fualaʻau o loʻo faʻatau atu nei Vyvanse (Ridexamphetamine Dimesylate Capsules) ma Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), o le AZSTARYS e i ai le aoga o le vave amata ona o le vave tatalaina o le d-MPH. Faʻatusatusa i le Adderall XR (amphetamine complex salt salt-release capsules) ma le Focalin XR (dexmethylphenidate hydrochloride lagolagoina-faʻamalolo capsule), aua o SDX o se gaosi, e mafai ona faʻaititia ai le faʻamoemoeina o fualaʻau.

O se multicenter, lua-tauaso, faʻasolosolo, placebo-pulea, vaega III suesuega (NCT03292952) iloiloina le aoga o AZSTARYS. O le suʻesuʻega na faʻafaigaluegaina 150 tamaiti matutua 6-12 tausaga ma faʻamaonia ole ADHD. O iʻuga o le suʻesuʻega na faʻaalia ai pe a faʻatusatusa i le placebo vaega, o faʻailoga o tamaiti i le vaega a le AZSTARYS na faʻaleleia atili, ma o le SKAMP-C togi na faʻaititia e le averesi o le 5.4 togi faʻatusatusa i le kulupu vaega.

Talu ai o le AZSTARYS e iai le d-MPH, o le Vasega II faʻatonutonu vailaʻau, ua fautuaina e le FDA ia AZSTARYS faʻavasegaina foʻi e tusa ma Vasega II faʻatonutonu vailaʻau. AZSTARYS o le a faʻatau atu i le taumafanafana o le 2021.