Tsoom Fwv Teb Chaws Asmeskas FDA pom zoo Qelbre (viloxazine) rau kev saib xyuas qhov ua tsis txaus siab hyperactivity tsis meej

Supernus Pharma yog lub tuam txhab kev tshaj lij biopharmaceutical tsom rau kev txhim kho thiab kev lag luam tshuaj rau kev kho mob rau cov kab mob nruab nrab (CNS). Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Qelbree (viloxazine), cov tshuaj serotonin-norepinephrine modulator (SNMA) rau kev kho mob ntawm 6-17 xyoo uas muaj hnub nyoog saib xyuas cov neeg mob uas muaj kev puas tsuaj hyperactivity tsis txaus (ADHD) Cov.

Nws tsim nyog teev tias Qelbree sawv cev rau thawj qhov kev kho mob tsis txaus ntseeg hauv kev kho tus mob ADHD hauv kaum xyoo. Supernus npaj yuav tso Qelbree hauv Asmeskas lub lag luam nyob rau lub hlis thib ob ntawm 2021. Hais txog kev noj tshuaj, Qelbree noj ntawm qhov ncauj ib hnub ib zaug, nqos tag nrho cov tshuaj ntsiav, lossis txau ntawm txiv applesauce.

Qelbree' s kev pom zoo raug txhawb nqa los ntawm cov ntaub ntawv tsim kho qhov project ntau ntxiv. Lub phiaj xwm muaj 4 ntu 3 kev sim tshuaj, kev rau npe ntau dua 1,000 menyuam yaus nrog ADHD hnub nyoog 6-17 xyoo. Thaum Lub Kaum Ob Hlis 2020, lub tuam txhab tshaj tawm tias Phase 3 sim nyob rau hauv cov neeg laus cov neeg mob ADHD tau txais txiaj ntsig zoo, thiab npaj yuav xa daim ntawv thov cov tshuaj ntxiv tshiab rau FDA xyoo thib ob ntawm 2021 siv Qelbree rau kev kho mob ntawm cov neeg laus nrog ADHD.

Nws tsim nyog pom tias Qelbree yuav nce kev xav tua tus kheej thiab tus cwj pwm hauv qee cov menyuam yaus nrog ADHD, tshwj xeeb tshaj yog nyob rau thawj ob peb lub hlis ntawm kev kho lossis thaum hloov cov koob tshuaj. Yog li, koj yuav tsum ua tib zoo saib xyuas txhua yam kev hloov pauv tshiab lossis maj nrawm hauv kev xav, kev coj tus cwj pwm, kev xav thiab kev xav. Ib qho ntxiv, cov neeg mob uas noj qee yam tshuaj tiv thaiv kev nyuaj siab, tshwj xeeb tshaj yog cov tshuaj monoamine oxidase inhibitors (MAOI), lossis qee yam tshuaj kho hawb pob, yuav tsum tsis txhob noj Qelbree.

Nkaus a. Khattar, Thawj Tswj Hwm thiab CEO ntawm Supernus, tau hais tias:" Raws li qhov ua tau zoo tshwm sim hauv qhov chaw pabcuam, peb ntseeg tias Qelbree yuav muab qhov kev xaiv tshiab rau kev kho ADHD. Qelbree yuav muab qhov kev xaiv tsis tau tshuaj rau cov kws kho mob thiab cov neeg mob ADHD. Ib txoj kev kho mob uas tau pom tseeb ua haujlwm zoo, nyab xeeb thiab tiv taus. Peb ua tsaug rau cov neeg mob, lawv tsev neeg thiab cov neeg saib xyuas lawv uas tau koom nrog thiab txhawb peb txoj kev tshawb fawb."

Andrew J. Cutler, MD, koom nrog cov kws saib xyuas mob hlwb ntawm North State Medical University, State University of New York thiab tus thawj coj kho mob ntawm lub koom haum ntawm Kev Tshawb Fawb Kev Tshawb Fawb tau hais tias:" ADHD yog ib qho ntawm cov teeb meem mob hlwb feem ntau hauv Tebchaws Meskas. Rau cov menyuam yaus thiab cov hluas, nws muaj tseeb. Txoj kev kho yog qhov tseem ceeb vim tias lawv loj hlob thiab loj hlob hauv tsev kawm ntawv thiab kev sib raug zoo. Qhov kev pom zoo no muab cov ntaub ntawv tshiab tsis tshaj lij uas tuaj yeem nchuav rau ntawm ib hnub ib zaug. Rau cov menyuam yaus thiab cov hluas nrog ADHD, nws yuav yog qhov kev xaiv zoo."