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.
He aha e lawe ʻia mai kēia ʻatikala:
- At a daily flexible-dose between 200mg to 600mg, the Phase III trial met the primary endpoint showing the reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo (p=0.
- The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
- “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.
