Kusukela ngo-2021-08-24, ama-cara zokwelapha kanye nomlingani wayo webhizinisi uVifor Pharma bamemezele ukuthi iziguli zappa zo-opioid zayo zokuqala ze-Kappa Opioid Receptor divelitbethalin (Korsuva ™ 2022Q1. UCara noVifor basayine isivumelwano selayisense esikhethekile sokuthengiswa kweKorsuva ™ e-United States futhi bavuma ukuthengisa iKorsuva ™ kuya kuFresenius Medical. Phakathi kwazo, uCara neVifor ne-vifa bane-60% ne-40% yenzuzo yabelana ngemali engenayo yokuthengisa ngaphandle kweFresenius Medical; Ngamunye unokuhlanganyela ngenzuzo engama-50% kwimali yokuthengisa evela eFresenius Medical.
I-CKD-Associated Pruritus (CKD-AP) iyisifemu esijwayelekile esenzeka ngokuvama okuphezulu nokuqina ezigulini ze-CKD ezihambisana ne-Dialysis. I-Prururitus yenzeka cishe ngo-60% -70% weziguli ezithola i-dialysis, lapho kuthi ama-30% -40% ane-pruritus ephakathi / enzima kakhulu, ethinta kakhulu ikhwalithi yempilo (isib. Akukho ukwelashwa okusebenzayo kwe-Pruritus ehlobene ne-CKD ngaphambili, futhi ukuvunywa kwe-diflikefalin kusiza ukubhekana negebe elikhulu lezokwelapha. Lokhu kuvunywa kususelwa ezivivinyweni ezimbili zeSigaba se-Pidiyo eziPidiyo ezifayiyo: Idatha enhle evela ku-Kalm-1 kanye ne-Kalm-2 izifundo zemitholampilo, futhi ekhombisa ukuthi uKorsuva ™ obekezelelekile kahle.
Kungekudala, izindaba ezinhle zaqhamuka ekutadisheni emtholampilo kwe-diflikefalin eJapan: 2022-1-11, uCara wamemezela ukuthi umjovo wayo uMaruishi Pharma noKissey Pharma bakuqinisekisile ukuthi umjovo we-rucuishi Isigaba sesi-III III COMRICTICAL CELDICE EKUPHELELE ISIQINISEKISO. Iziguli eziyi-178 zithola amasonto ayi-6 e-diflikefalin noma i-placebo futhi zibambe iqhaza ocwaningweni olungenwe lonke lwelebula elivulekile le-aul-ilebula. Isisekelo sokuqala (ushintsho ku-Pruritus Amanani Esilinganisweni Sokulinganisa Scale) kanye ne-Endpoint Secondary (Shintsha I-TRYTY Score on the Shiratori Rainity Scale) yathuthukiswa kakhulu kusuka eqenjini le-profikefalin uma liqhathaniswa neqembu le-placebo futhi labekezelelwa kahle.
Difelikefalin yisigaba se-opioid poptides. Ngokusekelwe kulokhu, Isikhungo Sokucwaninga Kwama-Perepde sifunde izincwadi eziku-Opioid Deptides, futhi safingqa ubunzima namasu ezinkundla ze-opioid ekuthuthukisweni kwezidakamizwa, kanye nesimo sokuthuthuka kwezidakamizwa esikhona.
Isikhathi sePosi: Feb-17-2022