Muamua fua fou ole dexmethylphenidate mo Tamaiti e iai le ADHD

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Corium, Inc. na faasilasila mai e faapea o lana pepa lautele, "Serdexmethylphenidate/d-Methylphenidate Capsules mo Tamaiti E iai le ADHD: Aafiaga ile SKAMP-C Iloiloina I luga ole 13 Itula i se Suʻesuʻega Vasega Aʻoga Faʻataʻitaʻi, Faʻalua-tauaso, Placebo-controlled Laboratory," o le a tuʻuina atu i. le Academy of Managed Care Pharmacy (AMCP) ia Mati 30, 2022, i Chicago, IL. Corium's oral capsule AZSTARYS (serdexmethylphenidate (SDX) ma le dexmethylphenidate (d-MPH) i aso taʻitasi, na faʻaleleia atili uma le mafaufau ma amioga i le 30-minute amata ma oʻo atu i le 13 itula o le umi i tamaiti e 6 i le 12 tausaga ua maua i le gauai. fa'aletonu o le hyperactivity ma'i (ADHD), fa'atusatusa i se placebo. O le a lipotia e le tusitala mea na maua (pepa tele # F21), mai se suʻesuʻega post hoc o se suʻesuʻega taua o le Vaega 3, i le AMCP.

Na fa'amaonia e le US Food and Drug Administration (FDA) le AZSTARYS o se togafitiga fa'atasi i aso ta'itasi o fa'ailoga ADHD i tagata mama'i ua ta'i 6 tausaga ma matutua atu i le aso 2 o Mati, 2021. O le AZSTARYS o le muamua ma na'o le vaila'au o lo'o iai le SDX, o le prodrug of d-MPH, lea e maua ai se umi fa'aumi o le fa'asalalauga d-MPH i le aso atoa. Ole AZSTARYS fa'atasi i aso ta'itasi e maua ile atunu'u ile US ile tolu SDX/fa'aola vave fa'aola ole malosi ole 26.1/5.2 mg, 39.2/7.8 mg, ma le 52.3/10.4 mg.

"O lenei auʻiliʻiliga o faʻamaumauga na aoina muamua i se suʻega taua e faʻaalia ai o le vave amataina ma le umi o le AZSTARYS e tuʻuina atu vave ma faaumiumi le aoga e pulea ai le gauai ma amioga i le aso o togafitiga o tagata maʻi ma le ADHD. O nei faʻaiʻuga e ofoina atu ai maʻi, matua, ma fomaʻi faʻapolofesa faʻamatalaga taua e mafaufau i ai pe a filifili i togafitiga faʻamaonia ADHD. Matou te talisapaia le avanoa e faʻasoa ai lenei faʻamatalaga i le AMCP, "o le tala lea a Charles Oh, MD, Ofisa Sili Fomaʻi o Corium.

O mea na maua e maua mai i se iloiloga o tagata auai i se suʻesuʻega potu suʻesuʻe e pulea placebo (NCT03292952), e faʻavae i luga o latou togi i luga o le Swanson, Kotkin, Agler, M-Flynn, ma Pelham (SKAMP) Fua Faʻatatau - Tuufaatasi (SKAMP-C). ). O le SKAMP-C ose fua fa'amaonia o amio a le potuaoga i tamaiti e iai le ADHD, fa'atasi ai ma togi maualalo e fa'atusalia ai le fa'aleleia atili ma le fa'aitiitia o fa'ailoga ADHD. O tamaiti, o le averesi o latou tausaga e 9.6 tausaga, na ave le SKAMP-C aʻo leʻi mauaina le AZSTARYS poʻo le placebo ona faʻavalu taimi pe a uma le tui, amata i le 30 minute ona sosoo ai lea ma itula 1, 2, 4, 8, 10, 12 ma 13.

Ole fua fa'atatau ile fa'ata'ita'iga ole averesi suiga ile sikoa SKAMP-C a'o le'i fa'asuia ma fa'asolo atu ile tele o taimi ile vasega ole aso. O le suʻesuʻega post hoc na faia e faʻaoga ai faʻamaumauga ma isi faʻataʻitaʻiga faʻataʻitaʻiga a le MPH, lea na faʻaaogaina le taeao o le potuaoga, poʻo se suʻesuʻega suʻesuʻega tutusa, e fai ma faʻavae mo togi SKAMP-C muamua.

O suiga averesi i SKAMP-C togi averesi i taimi uma fuataga na matua faʻaleleia e -5.41 points (p<0.001) mo tagata auai e mauaina AZSTARYS faʻatusatusa ia i latou na mauaina le placebo, faʻatasi ai ma suiga o togi o le -4.87 vs. 0.54. E fa'apena fo'i, o togi a le SKAMP-C ile su'esu'ega post hoc na fa'aalia ai le fa'aleleia atili o tamaiti na togafitia ile AZSTARYS fa'atusatusa ile vaega ole placebo. O le amataga o le togafitiga na amata ile 30 minute ina ua maeʻa le tuʻuina atu, faʻatasi ai ma se eseesega tele o togi o le -3.97 i le va o kulupu (P<0.001), ma faʻaauau mo 13 itula pe a maeʻa le tuʻuina atu, faʻatasi ai ma se eseesega tele o togi o le -3.49 (P = 0.004).

Na lipotia e tagata suʻesuʻe e leai ni faʻalavelave matuia (AEs) i le suʻesuʻega. O AE na lipotia e masani lava o togafitiga o le methylphenidate, ma o le toʻatele na faʻamauina e laʻititi i le feololo i le mamafa. O na AE e tupu soo i le vaega ASZTARYS (i le 2 pasene poʻo le sili atu o tagata auai) faʻatusatusa i le placebo vaega o le ulu tiga (5.4 vs. 1.3 pasene, AZSTARYS ma placebo faasologa), tiga o le manava pito i luga (4.1 vs. 1.3 pasene), le moe (2.7 vs. 1.3 pasene), ma le pharyngitis (tiga fa'a'i) (2.7 vs. 0 pasene).

O le faamasinoga na lesitala ai tamaiti e 155 mai le 6 i le 12 tausaga i le tolu-vaiaso, tatala-igoa faʻasologa o fualaʻau vaega. Mai na tamaiti, 150 na faʻavasegaina i se fitu aso, lua-tauaso, placebo-pulea togafitiga.

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Avatar a Linda Hohnholz

Linda Hohnholz

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