Sabon samfurin farko na dexmethylphenidate don Yara masu ADHD

A KYAUTA Kyauta 8 | eTurboNews | eTN
Avatar na Linda Hohnholz
Written by Linda Hohnholz

Corium, Inc. ya sanar da cewa hoton sa, "Serdexmethylphenidate / d-Methylphenidate Capsules ga Yara tare da ADHD: Tasirin SKAMP-C An kimanta Sama da Sa'o'i 13 a cikin Randomized, Double-makafi, Nazarin Azuzuwan Laboratory Control Placebo," za a gabatar a Kwalejin Kwalejin Kula da Magunguna (AMCP) a ranar Maris 30, 2022, a Chicago, IL. Corium's capsule na baka na yau da kullun sau ɗaya a rana AZSTARYS (serdexmethylphenidate (SDX) da dexmethylphenidate (d-MPH)) ya inganta sosai da hankali da ɗabi'a tare da farawa na mintuna 30 kuma har zuwa awanni 13 na tsawon lokaci a cikin yara masu shekaru 6 zuwa 12 da aka gano tare da kulawa. kasawa hyperactivity cuta (ADHD), idan aka kwatanta da placebo. Mawallafi zai ba da rahoton binciken (poster # F21), daga bincike mai zurfi na wani muhimmin nazari na Mataki na 3, a AMCP.

Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da AZSTARYS a matsayin magani na yau da kullun na alamun ADHD a cikin marasa lafiya masu shekaru 6 da haihuwa a ranar Maris 2, 2021. wanda ke ba da ƙarin tsawon lokacin sakin d-MPH a cikin yini. Ana samun AZSTARYS sau ɗaya kowace rana a cikin ƙasa a cikin Amurka a cikin SDX uku/sakin-saki d-MPH ƙarfi na 26.1/5.2 mg, 39.2/7.8 mg, da 52.3/10.4 MG.

"Wannan bincike na bayanan da aka tattara a baya a cikin gwaji mai mahimmanci ya nuna cewa saurin farawa da kuma tsawon lokaci na AZSTARYS yana ba da damar da wuri da kuma tsayin daka don sarrafa hankali da hali a duk lokacin jiyya na marasa lafiya tare da ADHD. Waɗannan sakamakon suna ba marasa lafiya, iyaye, da ƙwararrun kiwon lafiya bayanai masu mahimmanci don yin la'akari da lokacin zabar tsakanin ingantattun jiyya na ADHD. Muna godiya da damar da aka ba mu don raba wannan bayanan a AMCP, "in ji Charles Oh, MD, Babban Jami'in Lafiya na Corium.

Sakamakon binciken ya fito ne daga kimantawa na mahalarta a cikin nazarin azuzuwan dakin gwaje-gwaje masu sarrafa wuri (NCT03292952), dangane da makinsu akan Swanson, Kotkin, Agler, M-Flynn, da Pelham (SKAMP) Rating Scale - Haɗe (SKAMP-C). ). SKAMP-C ingantaccen ma'auni ne na ɗabi'un aji a cikin yara masu ADHD, tare da ƙananan ƙima suna wakiltar haɓakawa da rage alamun ADHD. Yaran, wadanda matsakaicin shekarun su ya kai shekaru 9.6, sun dauki SKAMP-C kafin su karbi AZSTARYS ko placebo sannan sau takwas bayan alluran, suna farawa daga mintuna 30 sannan a sa'o'i 1, 2, 4, 8, 10, 12 da 13.

Ma'aunin inganci na farko a cikin gwajin shine matsakaicin canji a cikin makin SKAMP-C daga gabanin yin allurai sannan kuma a lokuta da yawa yayin ranar aji. An gudanar da binciken bayan hoc don daidaita bayanan tare da wasu ƙirar gwaji na asibiti na MPH, waɗanda suka yi amfani da safiya na ranar aji, ko ziyarar nazarin kwatance, a matsayin tushen makin SKAMP-C kafin magani.

Matsakaicin sauye-sauye a cikin ma'aunin SKAMP-C da aka daidaita a duk matakan lokaci an inganta su ta hanyar -5.41 maki (p<0.001) don mahalarta da ke karɓar AZSTARYS idan aka kwatanta da waɗanda ke karɓar placebo, tare da sauye-sauye na -4.87 vs. 0.54. Hakazalika, ƙididdigar SKAMP-C a cikin bincike na baya-bayan nan ya nuna gagarumin ci gaba ga yara da aka bi da su tare da AZSTARYS idan aka kwatanta da ƙungiyar placebo. Farawar tasirin magani ya fara ne a cikin mintuna 30 bayan yin amfani da shi, tare da babban bambanci mai mahimmanci na -3.97 tsakanin ƙungiyoyi (P<0.001), kuma ya ci gaba har tsawon sa'o'i 13 bayan yin amfani da shi, tare da babban bambanci na -3.49 (P=0.004).

Masu bincike sun ba da rahoton wani mummunan mummunan al'amura (AEs) a cikin binciken. AEs da aka ruwaito sun kasance irin na maganin methylphenidate, kuma yawancin an ƙididdige su a matsayin mai sauƙi zuwa matsakaici a cikin tsanani. Wadannan AEs da ke faruwa akai-akai a cikin kungiyar ASZTARYS (a cikin kashi 2 ko fiye na mahalarta) idan aka kwatanta da ƙungiyar placebo sun kasance ciwon kai (5.4 vs. 1.3 bisa dari, AZSTARYS da placebo bi da bi), ciwon ciki na sama (4.1 vs. 1.3 bisa dari), rashin barci (2.7 vs. 1.3 bisa dari), da pharyngitis (ciwon makogwaro) (2.7 vs. 0 bisa dari).

Gwajin ya shigar da yara 155 masu shekaru 6 zuwa 12 a cikin mako uku, budadden lokaci na inganta kashi. Daga cikin waɗancan yaran, 150 sun kasance bazuwar zuwa kwana bakwai, makafi biyu, lokacin jiyya da ke sarrafa placebo.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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