labarai

A ranar 2 ga Maris, FDA ta Amurka ta amince da sabon aikace-aikacen magani (NDA) don AZSTARYS (sunan lamba: KP415), sau ɗaya a rana, don maganin cututtukan cututtukan rashin kulawa na hankali (ADHD) ga marasa lafiya shekaru 6 zuwa sama. Za a kasuwanci a Amurka. Zuwa
AZSTARYS wani nau'in kwaya ne mai hade da dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) da sakin d-MPH nan da nan. AZSTARYS ya ƙunshi 30% sakin nan da nan d-MPH da 70% faɗaɗa saki sabon SDX. Bayan an shanye shi ta hanyar kayan ciki, SDX ya koma d-MPH, kuma d-MPH ana sake shi a hankali a cikin rana.
Idan aka kwatanta da magungunan Vyvanse na yanzu (Ridexamphetamine Dimesylate Capsules) da Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS yana da fa'idar farawa nan take saboda sakin d-MPH da sauri. Idan aka kwatanta da Adderall XR (amphetamine hadadden gishiri mai dorewa-saki kawunansu) da Focalin XR (dexmethylphenidate hydrochloride dorewa-sakin kawunansu), saboda SDX kayan aiki ne, yana iya rage dogaro da ƙwayoyi.

Masana da yawa, makafi biyu, bazuwar, sarrafa wuribo, nazarin lokaci na III (NCT03292952) ya kimanta ingancin AZSTARYS. Binciken ya tattara yara 150 masu shekaru 6-12 tare da ganewar asali na ADHD. Sakamakon binciken ya nuna cewa idan aka kwatanta da rukunin wuribo, alamomin yara a cikin rukunin AZSTARYS sun inganta sosai, kuma an rage darajar SKAMP-C da kimanin maki 5.4 idan aka kwatanta da rukunin wuribo.

Tunda AZSTARYS ya ƙunshi d-MPH, wanda shine abu mai sarrafawa na II, FDA ta bada shawarar cewa AZSTARYS suma a sanya su daidai da abubuwan da ake sarrafawa na Class II. AZSTARYS za'a sayar dashi a lokacin rani na 2021.