ʻO ka holomua noiʻi o nā peptides opioid mai ka ʻae ʻana o Difelikefalin

I ka hoʻomaka ʻana o 2021-08-24, ua hoʻolaha ʻo Cara Therapeutics a me kāna hoa ʻoihana ʻo Vifor Pharma ua ʻae ʻia kāna kappa opioid receptor agonist difelikefalin (KORSUVA™) mua i ka papa no ka mālama ʻana i nā maʻi maʻi maʻi maʻi (CKD). (maikaʻi maikaʻi / ʻeha nui me ka hemodialysis lapaʻau), manaʻo ʻia e hoʻokuʻu ʻia i 2022Q1.Ua pūlima ʻo Cara lāua ʻo Vifor i kahi ʻaelike laikini kūʻokoʻa no ka hoʻolaha ʻana o KORSUVA™ ma ʻAmelika Hui Pū ʻIa a ua ʻae e kūʻai aku iā KORSUVA™ iā Fresenius Medical.Ma waena o lākou, ʻo Cara lāua ʻo Vifor he 60% a me 40% ka loaʻa kālā i nā loaʻa kūʻai aku ma mua o Fresenius Medical;he 50% ka loaʻa kālā o kēlā me kēia i ka loaʻa kālā mai Fresenius Medical.

ʻO ka pruritus pili i ka CKD (CKD-aP) kahi maʻi maʻi maʻamau i loaʻa me ke alapine kiʻekiʻe a me ka ikaika i nā poʻe maʻi CKD e hele ana i ka dialysis.Loaʻa ka Pruritus ma kahi o 60% -70% o nā mea maʻi e loaʻa ana i ka dialysis, a ʻo 30% -40% i loaʻa i ke ʻano haʻahaʻa/koʻikoʻi pruritus, e hoʻopilikia nui i ka maikaʻi o ke ola (e laʻa, maikaʻi ʻole ka hiamoe) a pili pū me ke kaumaha.ʻAʻohe lāʻau lapaʻau kūpono no ka pruritus pili i ka CKD ma mua, a ʻo ka ʻae ʻana o Difelikefalin e kōkua i ka hoʻoponopono ʻana i ka nui o ka pilikia olakino.Hoʻokumu ʻia kēia ʻae ʻana i ʻelua mau hoʻokolohua lapaʻau Phase III nui i ka waiho ʻana i ka NDA: nā ʻikepili maikaʻi mai ka hoʻāʻo ʻana o KALM-1 a me KALM-2 ma US a ma ka honua holoʻokoʻa, a me nā ʻikepili kākoʻo mai 32 mau noiʻi lapaʻau hou, e hōʻike ana ua ʻae maikaʻi ʻia ʻo KORSUVA ™. .

ʻAʻole i liʻuliʻu, ua hiki mai ka nūhou maikaʻi mai ke aʻo ʻana o ka difelikefalin ma Iapana: 2022-1-10, ua hoʻolaha ʻo Cara i kāna mau hoa ʻo Maruishi Pharma a me Kissey Pharma i hōʻoia i ka hoʻohana ʻana o difelikefalin injection ma Iapana no ka mālama ʻana i ka pruritus i nā maʻi hemodialysis.Nā hoʻokolohua lapaʻau Phase III Ua hoʻokō ʻia ka hopena mua.Ua loaʻa i nā maʻi 178 he 6 mau pule o ka difelikefalin a i ʻole placebo a komo i kahi haʻawina hoʻonui 52-week open-label extension.Ua hoʻomaikaʻi maikaʻi ʻia ka helu hope mua (ka hoʻololi ʻana i ka helu pruritus numerical scale scale) a me ka helu hope lua (hoʻololi i ka helu ʻino ma ka Shiratori Severity Scale) mai ka papa kuhikuhi i ka hui difelikefalin i hoʻohālikelike ʻia me ka hui placebo a ua ʻae maikaʻi ʻia.

ʻO Difelikefalin kahi papa o nā peptides opioid.Ma muli o kēia, ua aʻo ʻo Peptide Research Institute i nā palapala e pili ana i nā peptides opioid, a hōʻuluʻulu i nā pilikia a me nā hoʻolālā o nā peptides opioid i ka hoʻomohala ʻana i ka lāʻau lapaʻau, a me ke kūlana hoʻomohala lāʻau i kēia manawa.