I-Corium, Inc. ibhengeze ukuba ipowusta yayo, "i-Serdexmethylphenidate/d-Methylphenidate Capsules kubantwana abane-ADHD: Iimpembelelo kwi-SKAMP-C eVavanywe ngaphezu kweeyure ze-13 kwiSifundo seKlasi yeLabhoratri elawulwa yiLabhoratri eRandomized, ephindwe kabini, elawulwa yi-Placebo," iya kuboniswa apha. i-Academy of Managed Care Pharmacy (AMCP) ngo-Matshi 30, 2022, e-Chicago, IL. I-capsule yomlomo ye-Corium kanye ngosuku i-AZSTARYS (serdexmethylphenidate (SDX) kunye ne-dexmethylphenidate (d-MPH)), iphucule ngokubonakalayo kokubili ingqwalasela kunye nokuziphatha nge-30-minute yokuqala kunye nokuya kwiiyure ze-13 ubude kubantwana abaneminyaka eyi-6 ukuya kwi-12 yeminyaka efunyenwe ingqalelo. i-deficit hyperactivity disorder (ADHD), xa kuthelekiswa ne-placebo. Umbhali uya kunika ingxelo ngeziphumo (ipowusta # F21), kuhlalutyo lwesithuba sesithuba sophononongo olubalulekileyo lweSigaba sesi-3, kwi-AMCP.
I-US Food and Drug Administration (FDA) yamkele i-AZSTARYS njengonyango lwemihla ngemihla lweempawu ze-ADHD kwizigulana ezineminyaka eyi-6 nangaphezulu nge-2 kaMatshi 2021. I-AZSTARYS lelonayeza lokuqala nekuphela kwalo eliqulethe iSDX, iprodrug ye-d-MPH, ebonelela ixesha elongeziweyo lokukhutshwa kwe-d-MPH yonke imini. Kanye-imihla ngemihla i-AZSTARYS ifumaneka kuzwelonke e-US kwii-SDX ezintathu / ngokukhawuleza-ukukhululwa kwe-d-MPH amandla edosi ye-26.1 / 5.2 mg, 39.2 / 7.8 mg, kunye ne-52.3 / 10.4 mg.
“Olu hlahlelo lwedatha ebiqokelelwe ngaphambili kulingo olubalulekileyo lubonisa ukuba ukuqala okukhawulezayo kunye nexesha elide le-AZSTARYS kuzisa ukusebenza kwangethuba nangexesha elide ukulawula ingqalelo kunye nokuziphatha ngalo lonke usuku lonyango lwezigulana ezine-ADHD. Ezi ziphumo zinika abaguli, abazali, kunye nabasebenzi bezempilo ulwazi oluxabisekileyo ekufuneka luqwalaselwe xa ukhetha phakathi konyango oluqinisekisiweyo lwe-ADHD. Siyalixabisa ithuba lokwabelana ngale datha kwi-AMCP, "watsho uCharles Oh, MD, iGosa eliyiNtloko lezoNyango laseCorium.
Iziphumo zivela kuvavanyo lwabathathi-nxaxheba kuphononongo lwegumbi lebhubhoratri elilawulwa yi-placebo (NCT03292952), ngokusekelwe kumanqaku abo kwi-Swanson, Kotkin, Agler, M-Flynn, kunye ne-Pelham (SKAMP) Isikali sokulinganisa - Idityanisiwe (SKAMP-C ). I-SKAMP-C ngumlinganiselo oqinisekisiweyo wokuziphatha eklasini kubantwana abane-ADHD, ngamanqaku asezantsi amele ukuphucuka kunye nokuncipha kweempawu ze-ADHD. Abantwana, abanomndilili weminyaka eyi-9.6 ubudala, bathatha i-SKAMP-C phambi kokufumana i-AZSTARYS okanye i-placebo kwaye amaxesha asibhozo emva kwethamo, ukuqala ngemizuzu engama-30 kwaye emva koko ngeyure 1, 2, 4, 8, 10, 12 kunye ne-13.
Umlinganiselo ophambili wokusebenza kulingo yayiyi-avareji yotshintsho kumanqaku e-SKAMP-C ukusuka phambi kokudosa kunye namaxesha amaninzi ngexesha losuku lokufundela. Uhlalutyo lwe-post hoc lwenziwa ukulungelelanisa idatha kunye nolunye uyilo lolingo lwezonyango lwe-MPH, oluye lwasebenzisa ekuseni yosuku lokufundela, okanye utyelelo lophononongo olufaniswayo, njengesiseko samanqaku angaphambi konyango lwe-SKAMP-C.
Utshintsho oluqhelekileyo kumanqaku e-SKAMP-C aqikelelwa kuwo onke amanyathelo aphuculwe kakhulu ngamanqaku -5.41 (p <0.001) kubathathi-nxaxheba abafumana i-AZSTARYS xa kuthelekiswa nalabo bafumana indawo ye-placebo, kunye noshintsho lwamanqaku ahlukeneyo -4.87 vs. 0.54. Ngokufanayo, amanqaku e-SKAMP-C kuhlalutyo lwe-post hoc abonise ukuphucuka okubonakalayo kubantwana abaphathwa nge-AZSTARYS xa kuthelekiswa neqela le-placebo. Ukuqala kwesiphumo sonyango kwaqala ngemizuzu ye-30 emva kwe-dosing, kunye nokwahlukana okukhulu kwamanqaku -3.97 phakathi kwamaqela (P <0.001), kwaye yaqhubeka kwiiyure ze-13 emva kwe-dosing, kunye nokwahlukana okukhulu kwe-3.49 (P = 0.004).
Abaphandi babika ukuba akukho ziganeko ezimbi kakhulu (AEs) kwisifundo. Ii-AEs ezixeliweyo zaziqhelekile kunyango lwe-methylphenidate, kwaye uninzi lwalinganiswa njengobulali ukuya kumodareyitha kubunzima. Ezo zi-AEs ezenzeka rhoqo kwiqela le-ASZTARYS (kwi-2 ipesenti okanye ngaphezulu kwabathathi-nxaxheba) xa kuthelekiswa neqela le-placebo laliyintloko (i-5.4 vs. 1.3 ipesenti, i-AZSTARYS kunye ne-placebo ngokulandelanayo), intlungu yesisu esiphezulu (4.1 vs. ukuphuthelwa (1.3 vs. 2.7 ekhulwini), kunye ne-pharyngitis (umqala obuhlungu) (1.3 vs. 2.7 ekhulwini).
Ulingo lubhalise abantwana abali-155 ababudala buyiminyaka emi-6 ukuya kweli-12 kwisithuba seeveki ezintathu, isigaba sokwandisa ithamo evulelekileyo. Kulabo bantwana, i-150 yahlelwa ngokungenamkhethe kwiintsuku ezisixhenxe, i-double-blind-blind, ixesha lonyango elilawulwa yi-placebo.
INTO ONOKUYITHATHA KWELI NQAKU:
- 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.
