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 ye-felikefalin (KORSUVA™) yesigaba sokuqala yagunyazwa yi-FDA ukuze zelaphe iziguli zesifo sezinso esingamahlalakhona (CKD) (i-pruritus enhle emaphakathi/eqinile ngokwelashwa kwe-hemodialysis), kulindeleke ukuthi yethulwe ngo-2022Q1.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, okuthi 30% -40% yazo ibe ne-pruritus emaphakathi/eqinile, okuthinta kakhulu izinga lempilo (isb., izinga lokungalali kahle) futhi kuhlotshaniswa 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 III ekugcwaliseni kwe-NDA: idatha eyakhayo evela ocwaningweni lwe-KALM-1 kanye ne-KALM-2 e-US nasemhlabeni jikelele, kanye nedatha esekelayo evela ezifundweni zomtholampilo ezengeziwe ezingama-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-felikefalin 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.