Inqubekelaphambili yocwaningo lwama-peptide e-opioid kusukela ekuvunyweni kwe-Difelikefalin

Kusukela ngo-2021-08-24, i-Cara Therapeutics kanye nozakwabo ebhizinisini u-Vifor Pharma bamemezele ukuthi i-kappa opioid receptor agonist yesigaba sokuqala se-felikefalin (KORSUVA™) yagunyazwa yi-FDA yokwelapha isifo sezinso esingamahlalakhona (CKD) (i-pruritus enhle emaphakathi/eqinile nge-hemodia22 yokwelashwa). UCara noVifor basayine isivumelwano selayisense esikhethekile sokudayiswa kwe-KORSUVA™ e-United States futhi bavuma ukudayisa i-KORSUVA™ kuFresenius Medical. Phakathi kwazo, iCara neVifor ngayinye inesabelo senzuzo esingu-60% no-40% emalini engenayo yokuthengisa ngaphandle kweFresenius Medical; ngayinye inesabelo senzuzo esingu-50% emalini engenayo yokuthengisa evela kuFresenius Medical.

I-CKD-associated pruritus (CKD-aP) i-pruritus evamile eyenzeka ngokuvama okuphezulu kanye nokuqina ezigulini ze-CKD ezilashwa nge-dialysis. I-pruritus yenzeka cishe ku-60% -70% weziguli ezithola i-dialysis, lapho u-30% -40% une-pruritus emaphakathi/enzima, okuthinta kakhulu izinga lempilo (isb., izinga lokulala eliphansi) futhi lihlotshaniswa nokucindezeleka. Akukho ukwelashwa okusebenzayo kwe pruritus ehlobene ne-CKD ngaphambili, futhi ukuvunyelwa kwe-Difelikefalin kusiza ukubhekana negebe elikhulu lezidingo zezokwelapha. Lokhu kugunyazwa kusekelwe ezinhlolweni ezimbili ezibalulekile zomtholampilo zeSigaba sesi-III ekugcwaliseni kwe-NDA: idatha eyakhayo evela ovivinyweni lwe-KALM-1 ne-KALM-2 e-US nasemhlabeni jikelele, kanye nedatha esekelayo evela ezifundweni zomtholampilo ezengeziwe ezingu-32, ezibonisa ukuthi i-KORSUVA ™ ibekezelelwe kahle.

Muva nje, izindaba ezinhle zavela ocwaningweni lomtholampilo lwe-difelikefalin e-Japan: 2022-1-10, i-Cara yamemezela ukuthi ozakwethu uMaruishi Pharma no-Kissey Pharma baqinisekise ukuthi umjovo we-difelikefalin usetshenziswa e-Japan ekwelapheni i-pruritus ezigulini ze-hemodialysis. Izivivinyo zomtholampilo zeSigaba III Isiphetho esiyinhloko sahlangatshezwana nayo. Iziguli ezingu-178 zithole amaviki angu-6 e-difelikefalin noma i-placebo futhi zabamba iqhaza ocwaningweni lwamasonto angama-52 olunwetshiwe lwelebula evulekile. Iphoyinti lokugcina eliyinhloko (ushintsho kumphumela wesilinganiso sesilinganiso senombolo ye-pruritus) kanye nephoyinti lokugcina (ushintsho kumphumela wokulunywa ku-Shiratori Severity Scale) kuthuthukiswe kakhulu kusukela kwesisekelo eqenjini le-difelikefalin uma kuqhathaniswa neqembu le-placebo futhi kwabekezelelwa kahle.

I-Difelikefalin ikilasi lama-peptide e-opioid. Ngokusekelwe kulokhu, i-Peptide Research Institute ifunde izincwadi zama-opioid peptides, futhi yafingqa ubunzima namasu ama-opioid peptides ekuthuthukisweni kwezidakamizwa, kanye nesimo samanje sokuthuthukiswa kwezidakamizwa.