FDA pom zoo kev lag luam tawm kev tsim cov tshuaj tua kab mob sib txawv

Jazz Pharmaceuticals tau tshaj tawm hnub no tias Tsoomfwv Meskas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Xywav (calcium, magnesium, potassium, thiab sodium oxybate) qhov ncauj daws teeb meem Lub Xya Hli 21, 2020 rau kev kho mob ntawm narcolepsy 7 xyoo thiab laus dua Tus neeg mob' s cataplexy lossis pw tsaug zog ntau hnub nruab hnub (EDS). Xywav yog cov khoom lag luam sodium oxybate. Nws cov cim cationic sib xyaw ua rau muaj cov sodium ntsiab lus ntawm 92% qis dua cov kev kho mob sodium sodiumbbate tam sim no rau cov neeg mob no, txo cov kev pheej hmoo ntawm kev noj ntsev ntau ntxiv hauv cov neeg mob.

Narcolepsy yog ib hom mob ntsws ntev thiab tsis tshua hnov ​​mob neurological. Tus neeg mob muaj cov tsos mob ntawm kev tsaug zog vim qhov tsis muaj peev xwm los tswj lub voj voog ntawm kev tsaug zog thiab tsaug zog zoo li qub. Feem ntau cov narcolepsy yog tshwm sim los ntawm qhov tsis muaj hypocretin (ib qho neuropeptide hauv lub hlwb uas txhawb nqa qhov sib npaug ntawm kev pw tsaug zog thiab tsim kev tsaug zog). Tsib tsib cov tsos mob ntawm tus mob narcolepsy suav nrog kev pw tsaug zog ntau hnub nruab hnub, pib mob leeg sai (cataplexy), cuam tshuam kev pw tsaug zog thaum hmo ntuj, pw tsaug zog, thiab pw tsaug zog tuag tes tuag taw. Txhua tus neeg uas muaj narcolepsy yuav muaj cov tsos mob uas tsis tuaj yeem nyob tsaug zog thiab ceev faj thaum nruab hnub.

Xywav, tseem hu ua JZP-258, yog hom tshiab ntawm cov tshuaj oxygenbutyrate muaj li ntawm cov cations tshwj xeeb. Piv nrog Xyrem (sodium oxybate), lwm qhov kev tiv thaiv kab mob hauv lub plawv siv los ntawm Jazz los kho narcolepsy, cov ntsiab lus sodium raug txo qis los ntawm 92%, uas txhim kho kev nyab xeeb lub sijhawm ntev ntawm cov neeg mob' noj tshuaj. Thaum tam sim no, nws lub tshuab kiag ntawm kev nqis tes ua tseem tsis tau lees tias. Nws tau kwv yees hais tias kev kho mob ntawm JZP-258 rau narcolepsy yog ua raws li cov kev cai ntawm GABAB receptors thaum pw tsaug zog. Ntxiv rau, JZP-258 kuj tseem nyob rau Theem 3 qhov kev tshawb nrhiav tshuaj rau kev kho mob ntawm idiopathic hypersomnia.

Kev pom zoo ntawm FDA ntawm Xywav ua raws li lub ntiaj teb ob qhov muag tsis pom kev, tshuaj placebo, tswj kev soj ntsuam ntau qhov chaw muaj kev soj ntsuam qib 3, uas ua pov thawj kev ua tau zoo thiab kev nyab xeeb ntawm Xywav kho mob cataplexy thiab EDS hauv cov neeg mob narcolepsy. Txoj kev tshawb no muaj 201 tus neeg mob. Piv nrog pab pawg placebo, Xywav qhia pom muaj kev sib txawv ntawm cov lej cataplexy ntu toj ib asthiv thiab Epworth Sleepiness Scale cov qhab nia (p<>

GG quot; Raws li qhov ua tau zoo tshwm sim hauv qhov chaw kho mob, Xywav' s kev pom zoo yog qhov tseem ceeb heev rau cov neeg mob cataplexy lossis EDS ntsig txog narcolepsy," cov thawj coj ntawm theem 3 kev sim saib mob, Richard, tus kws tshaj lij pabcuam hauv tsev kawm qib siab hauv University of South Carolina Tsev Kawm Ntawv ntawm Tshuaj Dr. K. Bogan tau hais tias:" Qhov no yuav pab cov neeg mob ua raws li cov lus pom zoo kom noj ntsev txhua hnub. Kev noj tshuaj sodium ntau dhau yog txuam nrog kev ua kom ntshav siab, tawg, mob stroke thiab lwm yam kab mob plawv."