I-Corium, Inc. imemezele ukuthi iphosta yayo, “I-Serdexmethylphenidate/d-Methylphenidate Capsules Yezingane Ezine-ADHD: Imiphumela Ku-SKAMP-C Ihlolwe Ngamahora angu-13 Ocwaningweni Lwekilabhu Lelabhorethri Elilawulwa Ngokungahleliwe, Elingaboni Kabili, Elilawulwa yi-Placebo,” izokwethulwa i-Academy of Managed Care Pharmacy (AMCP) ngoMashi 30, 2022, e-Chicago, IL. Ikhephulethi yomlomo ye-Corium kanye ngosuku i-AZSTARYS (serdexmethylphenidate (SDX) ne-dexmethylphenidate (d-MPH)), ithuthukise ngokuphawulekayo kokubili ukunaka nokuziphatha ngokuqalwa kwemizuzu engama-30 nokufika emahoreni angu-13 obude ezinganeni ezineminyaka engu-6 kuya kwengu-12 ezitholwe zinakwa. i-deficit hyperactivity disorder (ADHD), uma iqhathaniswa ne-placebo. Umbhali uzobika okutholakele (iphosta # F21), kusukela ekuhlaziyweni kwesikhashana kocwaningo olubalulekile lweSigaba sesi-3, ku-AMCP.
I-US Food and Drug Administration (FDA) igunyaze i-AZSTARYS njengokwelashwa kanye ngosuku kwezimpawu ze-ADHD ezigulini ezineminyaka engu-6 nangaphezulu ngoMashi 2, 2021. I-AZSTARYS umuthi wokuqala nowukuphela kwawo oqukethe i-SDX, i-d-MPH, okunikeza ubude besikhathi obunwetshiwe bokukhishwa kwe-d-MPH usuku lonke. I-AZSTARYS yansuku zonke itholakala kuzwelonke e-US ngamandla amathathu ethamo le-d-MPH ye-SDX/ekhishwa ngokushesha engu-26.1/5.2 mg, 39.2/7.8 mg, kanye no-52.3/10.4 mg.
“Lokhu kuhlaziywa kwedatha eqoqwe ngaphambilini ovivinyweni olubalulekile kukhombisa ukuthi ukuqala ngokushesha kanye nesikhathi eside se-AZSTARYS kunikeza amandla kusenesikhathi nangesikhathi eside ukulawula ukunaka nokuziphatha kulo lonke usuku lokwelashwa kweziguli ezine-ADHD. Le miphumela inikeza iziguli, abazali, kanye nabasebenzi bezempilo ulwazi olubalulekile okufanele lucatshangelwe lapho kukhethwa phakathi kokwelashwa kwe-ADHD okuqinisekisiwe. Siyalithokozela ithuba lokwabelana ngale datha ku-AMCP,” kusho u-Charles Oh, MD, Isikhulu Esiyinhloko Sezokwelapha sase-Corium.
Okutholakele kuvela ekuhlolweni kwababambe iqhaza ocwaningweni lwekilabhu lelabhorethri elilawulwa yi-placebo (NCT03292952), ngokusekelwe kuzikolo zabo ku-Swanson, Kotkin, Agler, M-Flynn, kanye ne-Pelham (SKAMP) Isikali Sokulinganisa - Sihlanganisiwe (SKAMP-C ). I-SKAMP-C isilinganiso esiqinisekisiwe sokuziphatha kwasekilasini ezinganeni ezine-ADHD, enamaphuzu aphansi amelela ukuthuthukiswa kanye nokuncipha kwezimpawu ze-ADHD. Izingane, ezineminyaka engu-9.6 ubudala, zathatha i-SKAMP-C ngaphambi kokuthola i-AZSTARYS noma i-placebo futhi izikhathi eziyisishiyagalombili ngemva kokudoswa, ziqala ngemizuzu engama-30 bese kuba ngamahora angu-1, 2, 4, 8, 10, 12 kanye ne-13.
Isilinganiso esiyinhloko sokusebenza esivivinyweni sasiwushintsho olumaphakathi kumphumela we-SKAMP-C kusukela ngaphambi kokudosa kanye nasezikhathini eziningi phakathi nosuku lokufundela. Ukuhlaziywa kwe-post hoc kwenziwe ukuze kuqondiswe idatha neminye imiklamo yesilingo somtholampilo se-MPH, esebenzise ekuseni yosuku lokufundela, noma ukuvakasha kocwaningo okufanekisayo, njengesisekelo semiphumela ye-SKAMP-C yangaphambi kwemithi.
Isilinganiso sezinguquko kumaphuzu e-SKAMP-C anesilinganiso esilinganisiwe kuzo zonke izilinganiso zesikhathi sithuthukiswe kakhulu ngamaphuzu angu--5.41 (p<0.001) kubahlanganyeli abathola i-AZSTARYS uma kuqhathaniswa nalabo abathola i-placebo, nezinguquko zamaphuzu ngokulandelana kwazo -4.87 vs. 0.54. Ngokufanayo, amaphuzu e-SKAMP-C ekuhlaziyweni kwe-post hoc abonise ukuthuthuka okukhulu ezinganeni ezilashwa nge-AZSTARYS uma kuqhathaniswa neqembu le-placebo. Ukuqala komphumela wokwelashwa kwaqala emaminithini angu-30 ngemva kokuthatha umthamo, ngomehluko omkhulu wamaphuzu -3.97 phakathi kwamaqembu (P<0.001), futhi waqhubeka amahora angu-13 ngemva kokudosa, ngomehluko omkhulu wamaphuzu -3.49 (P=0.004).
Abaphenyi babike ukuthi azikho izehlakalo ezimbi kakhulu (ama-AE) ocwaningweni. Ama-AE abikiwe ayejwayelekile ekwelashweni kwe-methylphenidate, futhi iningi lakalwa njengokuthambile kuya kokulinganisela ngobunzima. Lawo ma-AE avela kaningi eqenjini le-ASZTARYS (kumaphesenti angu-2 noma ngaphezulu kwabahlanganyeli) uma kuqhathaniswa neqembu le-placebo lalikhanda ikhanda (i-5.4 vs. 1.3 amaphesenti, i-AZSTARYS kanye ne-placebo ngokulandelana), ubuhlungu obungaphezulu besisu (4.1 vs. 1.3 amaphesenti), ukuqwasha (2.7 vs. 1.3 amaphesenti), kanye ne-pharyngitis (umphimbo obuhlungu) (2.7 vs. 0 amaphesenti).
Isivivinyo sibhalise izingane ezingu-155 ezineminyaka engu-6 kuya kwengu-12 esigabeni sokuthuthukisa umthamo esingamaviki amathathu, esinelebula evulekile. Kulezo zingane, i-150 ihlelwe ngokungahleliwe ibe yizinsuku eziyisikhombisa, i-double-blind, inkathi yokwelashwa elawulwa yi-placebo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- 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.
