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Pa Marichi 2, US FDA idavomereza kugwiritsa ntchito mankhwala osokoneza bongo (NDA) a AZSTARYS (dzina lakhodi: KP415), kamodzi patsiku, kuti athetse vuto la kuchepa kwa matenda (ADHD) mwa odwala azaka 6 kapena kupitilira apo. Adzachita malonda ku United States. Kuti
AZSTARYS ndi mawonekedwe apakompyuta okhala ndi dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) ndikumasulidwa kwanthawi yomweyo d-MPH. AZSTARYS ili ndi 30% yotulutsa d-MPH pomwe 70% idatulutsa SDX yatsopano. Pambuyo poyamwa kudzera m'matumbo, SDX imasinthidwa kukhala d-MPH, ndipo d-MPH imatulutsidwa pang'onopang'ono pasanathe tsiku limodzi.图片2
Poyerekeza ndi mankhwala omwe akugulitsidwa pano a Vyvanse (Ridexamphetamine Dimesylate Capsules) ndi Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS ili ndi mwayi woyambira posachedwa chifukwa cha d-MPH. Poyerekeza ndi Adderall XR (amphetamine complex salt capsule-release capsules) ndi Focalin XR (dexmethylphenidate hydrochloride supplements-release capsules), chifukwa SDX ndi prodrug, imatha kuchepetsa kudalira mankhwala.
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Kafukufuku wambiri, wakhungu kawiri, wosasinthika, wowongolera ma placebo, gawo lachitatu (NCT03292952) adawunika momwe AZSTARYS imagwirira ntchito. Kafukufukuyu adalemba ana 150 azaka zapakati pa 6 ndi 12 omwe amapezeka ndi ADHD. Zotsatira za kafukufukuyu zidawonetsa kuti poyerekeza ndi gulu la placebo, zisonyezo za ana mgulu la AZSTARYS zidasintha bwino, ndipo kuchuluka kwa SKAMP-C kunachepetsedwa ndi avareji ya mfundo 5.4 poyerekeza ndi gulu la placebo.
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Popeza AZSTARYS ili ndi d-MPH, yomwe ndi kalasi yachiwiri yolamulidwa, a FDA amalimbikitsa kuti AZSTARYS iyeneranso kugawidwa molingana ndi zinthu zoyendetsedwa ndi Class II. AZSTARYS adzagulitsidwa mchilimwe cha 2021.


Nthawi yamakalata: May-17-2021