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ozi

Na Machị 2, US FDA akwadoro ọgwụ ọgwụ ọhụrụ (NDA) maka AZSTARYS (aha koodu: KP415), otu ugboro n'ụbọchị, maka ọgwụgwọ ọrịa anya mpe mpe mpe anya (ADHD) na ndị ọrịa 6 afọ na okenye. Ga-ere ahịa na United States. Iji
AZSTARYS bụ onyinye usoro ọgwụ capsule mejupụtara dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) na ịtọhapụ ozugbo d-MPH. AZSTARYS nwere 30% ntọhapụ ozugbo d-MPH na 70% agbatịpụrụ ọhụrụ SDX. Mgbe etinyechara ya na eriri afọ, SDX gbanwere d-MPH, ma jiri nwayọọ nwayọọ wepụta d-MPH n'ime otu ụbọchị.图片2
E jiri ya tụnyere ọgwụ ndị a na-ere ahịa ugbu a bụ Vyvanse (Ridexamphetamine Dimesylate Capsules) na Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS nwere uru nke mbido ozugbo n'ihi ịhapụ ozugbo nke d-MPH. E jiri ya tụnyere Adderall XR (amphetamine complex salt sustained-release capsules) na Focalin XR (dexmethylphenidate hydrochloride sustained-release capsules), n’ihi na SDX bụ ọgwụ, ọ nwere ike belata ịdabere na ọgwụ.
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Onye na-enyocha ọtụtụ mmadụ, onye ìsì abụọ, nke a na-ahụkarị, nke a na-achịkwa, nke a na-achịkwa ebe a, usoro nke III (NCT03292952) tụlere ịdị irè nke AZSTARYS. Ọmụmụ ihe ahụ wepụtara ụmụaka 150 dị afọ 6-12 na nyocha nke ADHD. Nsonaazụ ọmụmụ ahụ gosipụtara na e jiri ya tụnyere otu placebo, ihe mgbaàmà nke ụmụaka nọ na otu AZSTARYS dịwanye mma, na akara SKAMP-C belatara na nkezi nke 5.4 isi ma e jiri ya tụnyere otu placebo.
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Ebe ọ bụ na AZSTARYS nwere d-MPH, nke bụ ihe a na-achịkwa klaasị II, FDA na-atụ aro ka ewepụta AZSTARYS dịka usoro ihe II na-achịkwa. AZSTARYS ga-ere ahịa n'oge ọkọchị nke 2021.


Post oge: Mee-17-2021