ʻAe ʻia ʻo FDA no ka mālama hou ʻana o ADHD i nā mākua

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Ua hoʻolaha ʻo Supernus Pharmaceuticals, Inc. ua ʻae ka US Food and Drug Administration (FDA) i kahi hōʻailona hoʻonui ʻia no Qelbree (viloxazine extended-release capsules) no ka mālama ʻana i ka maʻi maʻi maʻi maʻi maʻi maʻi he 18 a ʻoi aku. Ua ʻae ka FDA i kēia manawa iā Qelbree no ka mālama ʻana i ka ADHD i nā keiki (e hoʻomaka ana i ka makahiki 6), nā ʻōpio a me nā pākeke.

Ma kahi o 16 miliona mau keiki, ʻōpio, a me nā mākua i loaʻa iā ADHD i ka US ʻOiai ʻoi aku ka nui o nā keiki me ADHD ma mua o ia, a hiki i ka 90% o ka poʻe i loaʻa i ka ADHD i ka wā kamaliʻi e hoʻomau i ka ADHD ma ke ʻano he mau mākua.

"A hiki i kēia lā, ua kaupalena ʻia nā koho ADHD nonstimulant no nā pākeke," wahi a Greg Mattingly, MD, ka hoa hoʻokumu o St. Charles Psychiatric Associates ma St. Louis, Mo. miliona o nā poʻe mākua ʻAmelika e hoʻāʻo nei e ʻimi i ka lāʻau kūpono e mālama ai i kā lākou mau hōʻailona ADHD.

ʻO Qelbree kahi moʻolelo nonstimulant i lawe ʻia i hoʻokahi lā no ka hoʻolaha ʻana i ka lā piha. Ua ʻike mua ʻia ka maikaʻi a me ka hoʻomaikaʻi ʻana o nā hōʻailona ma ka mālama ʻana. Loaʻa iā ia kahi hōʻike palekana a me ka hoʻomanawanui ʻana, me ka ʻole o ka hōʻike o ka hiki ke hoʻomāinoino i nā haʻawina lapaʻau. Hoʻokumu ʻia ka ʻae ʻia ma nā hopena maikaʻi mai kahi haʻawina ʻo Qelbree i hoʻopaʻa ʻia ma kahi randomized, double blind, placebo-controlled Phase III i nā pākeke me ADHD a ke hōʻike nei i ka ʻae mua ʻana o kahi lāʻau lapaʻau nonstimulant no nā pākeke ma 20 mau makahiki.

"Ma ke ʻano he alakaʻi ma ke kahua o CNS, ua paʻa piha mākou i ka hoʻomaopopo maikaʻi ʻana i ka mālama ʻana i nā maʻi paʻakikī e like me ADHD," wahi a Jack Khattar, Pelekikena a Luna Nui o Supernus Pharmaceuticals. "ʻO ka ʻae ʻia o kēia lā kahi holomua nui i ka mālama ʻana iā ADHD a he mea koʻikoʻi koʻikoʻi i hoʻokahi makahiki ma hope o ka ʻae ʻia ʻana o Qelbree e mālama i nā maʻi pediatric. Haʻaheo mākou e lawe mai i kahi koho nonstimulant hou no nā pākeke i ka mākeke ma hope o ʻelua mau makahiki. "

I kēlā me kēia lā ma waena o 200mg a i 600mg, ua hālāwai ka Phase III i ka hopena mua e hōʻike ana i ka hōʻemi ʻana o ka hoʻololi ʻana mai ka pae kumu o ka ADHD Investigator Symptom Rating Scale (AISRS) ka nui o ka helu ma ka hopena o ke aʻo ʻana ua ʻoi aku ka nui o ka helu i nā pākeke. mālama ʻia me Qelbree me ka placebo (p=0.0040). Ua ʻike pū ʻia ka hoʻomaikaʻi nui ʻana i nā helu subscale AISRS o ka nānā ʻole a me nā hōʻailona hyperactivity / impulsivity i ke aʻo ʻana. Eia kekahi, ua hoʻokō ka haʻawina i ka hopena o ka hopena o ka hopena me ka nui o ka helu helu (p=0.0023) i ka hoʻololi ʻana mai ka baseline o ka Clinical Global Impression - Severity of Illness (CGI-S) Scale i ka pule 6. Ua ʻae maikaʻi ʻia ka lāʻau ikaika. E ʻoluʻolu e ʻike i nā ʻike palekana koʻikoʻi hou ma lalo.

Ua aʻo ʻia ʻo 1 Qelbree ma 4 mau hoʻokolohua lapaʻau. Ma hoʻokahi haʻawina o nā keiki 6 a hiki i 11 mau makahiki, ʻo ka hōʻemi ʻana i ka hōʻailona hōʻailona ADHD he mea koʻikoʻi nui no ka 100 mg a me 200 mg doses, e hoʻomaka ana i ka pule 1. Ma ke aʻo ʻana o nā ʻōpio 12 a hiki i 17 mau makahiki, ua hōʻemi ʻia nā hōʻailona hōʻailona ADHD i ka helu helu. He mea nui no 400 mg, e hoʻomaka ana i ka pule 2. Ma ke aʻo ʻana i ka maʻi maʻalahi o nā pākeke 18 a 65 mau makahiki, ʻoi aku ka nui o nā hōʻemi o ka hōʻailona ADHD i nā maʻi Qelbree, e hoʻomaka ana i ka pule 2.

IMFORMATION SAFETY IMPORTANT

Hiki paha iā Qelbree ke hoʻonui i nā manaʻo a me nā hana suicidal, i nā keiki a me nā pākeke me ADHD, ʻoi aku hoʻi i loko o nā mahina mua o ka mālama ʻana a i ʻole ke hoʻololi ʻia ka nui. E haʻi i kāu kauka inā loaʻa iā ʻoe (a inā he moʻolelo ʻohana) nā manaʻo suicidal a i ʻole nā ​​​​hana ma mua o ka hoʻomaka ʻana iā Qelbree. E nānā i kou mau naʻau, nā ʻano, nā manaʻo, a me nā manaʻo i ka wā o ka mālama ʻana me Qelbree. E hōʻike koke i nā hoʻololi hou a i ʻole i kēia mau hōʻailona. ʻAʻole pono e lawe ʻia ʻo Qelbree e nā poʻe maʻi e lawe pū ana i kekahi mau lāʻau anti-depression, ʻoi aku ka mea i kapa ʻia he monoamine oxidase inhibitor a i ʻole MAOI, a i ʻole kekahi mau lāʻau hānō.

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Linda Hohnholz

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