Tsoomfwv Meskas FDA tau tshem tawm Txoj Kev Kho Mob Txoj Haujlwm Ntawm Lub Hwjchim Norepinephrine Reuptake Inhibitor AXS-12!

Axsome Therapeutics tsis ntev los no tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) ceeb toom rau lub tuam txhab tias nws tau thim qhov kev tsim kho kev kho mob (BTD) rau AXS-12 (reboxetine) rau kev kho mob ntawm cov neeg mob narcolepsy nrog cataplexy. Qhov laj thawj yog tias tsis ntev tom qab AXS-12 BTD tau tso cai, FDA pom zoo lwm yam tshuaj rau kev kho mob cataplexy hauv cov neeg mob nrog narcolepsy. Axsome cia siab tias yuav tsis muaj kev hloov pauv rau AXS-12 txoj haujlwm kev txhim kho lossis cuam tshuam txog sijhawm raws li qhov tshwm sim.

Thaum Lub Yim Hli 2020, FDA tau tso cai AXS-12 BTD rau kev kho mob ntawm narcolepsy cataplexy. Tab sis thaum Lub Kaum Hli 2020, FDA pom zoo Wakix (pitolisant) rau kev kho mob cataplexy rau cov neeg laus nrog narcolepsy. Wakix yog thawj qhov tshuaj pom zoo los ntawm FDA uas tsis tau teev tseg los ntawm US Drug Administration (DEA) rau kev kho mob ntawm kev tsaug zog thaum nruab hnub ntau dhau lossis cataplexy cuam tshuam nrog narcolepsy. Hauv Tebchaws Meskas, Wakix tau pom zoo thawj zaug hauv 2019 rau kev kho mob ntawm kev tsaug zog thaum nruab hnub ntau dhau rau cov neeg laus uas muaj mob narcolepsy.

Wakix yog tshuaj yeeb yaj kiab. Nws cov khoom xyaw nquag, pitolisant, yog xaiv histamine 3 (H₃) receptor antagonist/trans-agonist, uas ua rau kom muaj kev sib txuas thiab tso tawm histamine los ntawm cov txheej txheem tshiab ntawm kev nqis tes ua. Amine yog cov tshuaj xa xov paj hlwb hauv lub paj hlwb uas txhawb kev tsaug zog. Hais txog kev siv tshuaj, Wakix tau hais qhia qhov ncauj, ib zaug txhua tag kis tom qab sawv los.

Narcolepsy yog mob hnyav, ua rau lub cev tsis muaj zog ua rau muaj kev tsaug zog ntau dhau thaum nruab hnub (EDS) thiab cataplexy, tom kawg yog qhov poob qis ntawm cov leeg nqaij ua rau muaj kev xav zoo. Tus kab mob yog tus kab mob uas kho tsis tau. Sij hawm dhau mus, lub nra ntawm tus kab mob yuav muaj kev cuam tshuam loj heev rau kev noj qab haus huv ntawm cov neeg mob.

AXS-12 (reboxetine) yog qhov tshiab, qhov ncauj, xaiv tau zoo, thiab muaj zog norepinephrine reuptake inhibitor rau kev kho mob ntawm narcolepsy. AXS-12 tuaj yeem tswj hwm kev ua haujlwm norepinephrine, txhawb kev tsaug zog, tswj cov leeg nqaij, thiab txhim kho kev txawj ntse. Yav dhau los, FDA kuj tau tso cai rau Orphan Drug Designation (ODD) rau AXS-12 rau kev kho mob ntawm narcolepsy.

Reboxetine muaj cov ntaub ntawv pov thawj kev nyab xeeb nyob hauv Europe thiab ntau dua 40 lub tebchaws thiab tau pom zoo rau kev kho kev nyuaj siab hauv cov tebchaws no. Lub luag haujlwm ntawm AXS-12 hauv narcolepsy tau txais kev txhawb nqa los ntawm qhov ua tau zoo preclinical thiab theem 2 cov txiaj ntsig kev kho mob. Cov ntaub ntawv qhia pom tias AXS-12 txo qis narcolepsy ntu hauv hypothalamicin (orexin) -deficient nas. Ib qho ntxiv, hauv kev sim qhib daim ntawv lo sim, AXS-12 tau txhim kho kev tsaug zog thaum nruab hnub thiab txo qis cataplexy hauv cov neeg mob nrog narcolepsy.

Yav dhau los, FDA tau tso cai AXS-12 BTD raws qhov txiaj ntsig zoo ntawm Phase II CONCERT txoj kev tshawb fawb. Qhov no yog qhov ua piv txwv, ob-qhov muag tsis pom, tswj cov placebo, hla, ntau lub tebchaws Asmeskas kev sim. Hauv kev sim, 21 tus neeg mob kuaj mob nrog narcolepsy nrog cataplexy tau kho nrog AXS-12 lossis cov placebo rau 2 lub lis piam, thiab tom qab ntawd hla kev kho tom qab 1-lub lim tiam txo qis thiab ntxuav lub sijhawm.

Cov txiaj ntsig tau qhia pom tias AXS-12 mus txog qhov kawg qhov kawg: piv nrog cov placebo, tus naj npawb nruab nrab ntawm kev tawm tsam cataplexy hauv ib lub lis piam (cuam tshuam rau kev kho mob tag nrho) thaum lub sijhawm kho mob 2 lub lis piam tau qis dua qhov pib (p< 0.001)="" ),="" qhov="" kawg="" ntawm="" 2-lub="" lim="" tiam="" kev="" kho="" mob="" tus="" naj="" npawb="" nruab="" nrab="" ntawm="" kev="" tawm="" tsam="" cataplexy="" hauv="" ib="" lub="" lis="" piam="" tau="" qis="" dua="" li="" qhov="" pib="" (p="0.002)." ib="" qho="" ntxiv,="" piv="" nrog="" cov="" placebo,="" axs-12="" kuj="" tseem="" txhim="" kho="" eds,="" raws="" li="" ntsuas="" los="" ntawm="" epworth="" sleepiness="" scale="" (ess)="" thiab="" zaus="" ntawm="" kev="" pw="" tsaug="" zog="" yuam="" kev="" (p="0.003" thiab="">< 0.001,="" feem).="" ib="" qho="" ntxiv,="" raws="" li="" kev="" soj="" ntsuam="" kab="" mob="" narcolepsy="" (nsaq-ac)="" cov="" txiaj="" ntsig="" ntsuas,="" thaum="" lub="" sijhawm="" kho="" 2-lub="" lim="" tiam,="" axs-12="" tau="" txhim="" kho="" kev="" paub="" zoo="" dua="" piv="" nrog="" cov="" placebo="">< 0.001).="" hauv="" qhov="" kev="" sim="" no,="" axs-12="" tau="" zam="" zoo,="" thiab="" qhov="" tshwm="" sim="" tsis="" zoo="" feem="" ntau="" yog="" kev="" ntxhov="" siab,="" cem="" quav="" thiab="" pw="" tsis="" tsaug="">