Otsuka Triple Reuptake Inhibitor Centanafadine 2 Tus Txheej Xwm Loj III Saib Xyuas Zoo!

Lub tuam txhab Japanese kws tshaj lij Otsuka Pharma thiab nws cov chaw muag khoom hauv Teb Chaws Asmeskas Otsuka Pharmaceutical Development thiab Commercialization Corp. nyuam qhuav tshaj tawm cov txiaj ntsig zoo ntawm ob lub lis piam 6 lub lis piam soj ntsuam kev tshuaj ntsuam xyuas qhov ncauj centanafadine rau kev kho mob ntawm kev saib xyuas kev cuam tshuam hyperactivity tsis meej (ADHD) hauv cov neeg laus tshwm sim.

Centanafadine yog triple reuptake inhibitor ntawm serotonin, norepinephrine, thiab dopamine, thiab tam sim no tau tsim kho rau cov neeg laus ADHD. Otsuka tseem npaj rau kev tshuaj xyuas cov tshuaj hauv kev kho menyuam yaus nrog ADHD thiab sib tham txog cov kauj ruam tom ntej nrog Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA).

Hauv kev tshawb nrhiav ob theem III no, kwv yees li ntawm 900 tus neeg mob hnub nyoog 18 thiab 55 xyoo uas tau kuaj pom tias muaj ADHD tau faib ua 2 pab pawg. Cov kev tshawb fawb no muaj randomized, ob lub qhov muag dig muag, ntau lub chaw, tshuaj placebo, nrog cov pab pawg sib tw ua ke. Cov neeg mob tau raug muab faib rau hauv 1: 1: 1 piv thiab tau txais centanafadine ntawm ib koob ntawm 100 mg lossis 200 mg ob zaug ib hnub (tag nrho cov koob tshuaj 200 mg lossis 400 mg, feem ntau), lossis placebo ob zaug ib hnub. Tam sim no, Otsuka tab tom ua txoj kev kawm ntev txog kev nyab xeeb thiab kev ua siab ntev ntawm centanafadine nrog qhov kev txhaj tshuaj txhua hnub ntawm 400 mg, thiab cia siab tias cov ntawv kawg yuav tau nyob hauv 2021.

centanafadine chemical structural mis (Cov duab los ntawm: Wikipedia)

Hauv cov kev tshawb fawb ob theem III, cov ntaub ntawv tau qhia tias centanafadine ntawm 200 mg thiab 400 mg ib zaug ib hnub pom kev txhim kho kev sib raug zoo ntawm ob qho tseem ceeb thiab qhov tseem ceeb thib ob kawg qhov kawg piv rau cov placebo.

Thawj qhov kev ua tau zoo kawg ntawm cov ntaub ntawv qhia tau pom tias hauv ob txoj kev tshawb nrhiav, qhov 200 mg thiab 400 mg koob tshuaj ntawm centanafadine tau qhia tawm qhov kev hloov pauv ntawm lub hauv paus mus rau hnub 42 hauv tag nrho cov qhab nia ntawm Cov Txheeb Xyuas ADHD Tus Neeg Soj Ntsuam' tso rau tso. Cov kev txhim kho tseem ceeb (p< 0.05="" hauv="" thawj="" qhov="" kev="" tshawb="" nrhiav="" thiab="">< 0.01="" hauv="" kev="" kawm="" thib="" ob).="" aisrs="" yog="" kev="" xam="" phaj="" raws="" kev="" ntsuas="" rau="" kev="" ntsuas="" adhd="" cov="" tsos="" mob="" rau="" cov="" neeg="" mob="" laus,="" suav="" nrog="" hyperactivity="" impulsivity="" thiab="" inattention="">

Cov ntsiab lus tseem ceeb thib ob kawg ntawm cov ntaub ntawv qhia tau pom tias hauv 2 qhov kev tshawb fawb, centanafadine kuj tseem muaj qhov hloov pauv hauv kev saib xyuas tag nrho-kev ua kom mob siab (CGI-S) los ntawm qhov pib mus rau hnub 42 piv rau cov placebo. Cov kev ntsuas pom tias muaj nuj nqis tseem ceeb (p<>

Hauv kev txheeb xyuas ntawm kev tshawb nrhiav 2 txoj kev tshawb nrhiav, feem ntau cov kev mob tshwm sim ntawm centanafadine (kwv yees li 5% kev tshwm sim thiab ntau zaus dua cov placebo) suav nrog kev noj tsis qab, mob taub hau, xeev siab, lub qhov ncauj qhuav, kab mob txha sauv, thiab zawv plab; tsis muaj kev tshuaj xyuas Qhov tshwm sim Cov neeg mob uas muaj qhov tshwm sim> 7%.

Raws li ADDA, kwv yees li 5% (11 lab) ntawm cov neeg laus hauv Tebchaws Meskas muaj ADHD, tus kabmob neurobehavioral uas cuam tshuam tshwj xeeb rau lub hlwb kev ua haujlwm thiab kev coj tus cwj pwm coj. Cov haujlwm hauv lub hlwb no suav nrog cov haujlwm tseem ceeb xws li kev saib xyuas, mloog, cim xeeb, kev mob siab thiab siv zog, kawm los ntawm kev ua yuam kev, ua tsis tau, ADHD, kev ua haujlwm thiab kev sib raug zoo. Tsis muaj kev paub kho tus mob ADHD, thiab feem ntau cov neeg tsis tuaj yeem tshem tus kab mob. Txog ob feem peb lossis ntau dua ntawm cov menyuam yaus nrog ADHD tseem muaj cov tsos mob thiab tus kab mob sib tw ntawm kev laus.