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.

OA MEA E AVEA MAI LENEI TUSI:

Corium’s once-daily oral capsule AZSTARYS (serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)), significantly improved both attention and behavior with a 30-minute onset and up to 13 hours of duration in children ages 6 to 12 years diagnosed with attention deficit hyperactivity disorder (ADHD), compared to a placebo.
“This analysis of data previously collected in a pivotal trial demonstrates that the fast onset and long duration of AZSTARYS delivers early and prolonged efficacy to manage attention and behavior throughout the treatment day of patients with ADHD.
The post hoc analysis was conducted to align the data with other MPH clinical trial designs, which have used the morning of the classroom day, or an analogous study visit, as the baseline for pre-medication SKAMP-C scores.