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

I ka makahiki 2021-08-24, ua hoʻolaha ʻo Cara Therapeutics a me kāna hoa ʻoihana ʻo Vifor Pharma ua ʻae ʻia kāna agonist kappa opioid receptor agonist difelikefalin (KORSUVA™) mua-ma ka papa no ka mālama ʻana i nā maʻi maʻi maʻi maʻi (CKD) (positive Moderate/severe pruritus with hemodialysis treatment), ua manaʻo ʻia e hoʻokuʻu ʻia i 12022Q. 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; Loaʻa i kēlā me kēia me 50% ka loaʻa kālā i nā loaʻa kūʻai mai Fresenius Medical.

ʻO ka maʻi maʻi pili i ka CKD (CKD-aP) kahi maʻi maʻi maʻamau i loaʻa me ke alapine kiʻekiʻe a me ka ikaika i nā 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 ka maʻi maʻemaʻe/koʻikoʻi, 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 pono lapaʻau. Hoʻokumu ʻia kēia ʻae ʻia ma nā hoʻokolohua lapaʻau Phase III pivotal ma ka waiho ʻana i ka NDA: nā ʻikepili maikaʻi mai nā hoʻokolohua KALM-1 a me KALM-2 i ka US a me ka honua, 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 ua hōʻoia kāna mau hoa ʻo Maruishi Pharma a me Kissey Pharma e hoʻohana ʻia ka 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 difelikefalin a i ʻole placebo a komo i kahi haʻawina hoʻopaneʻe inoa wehe ʻia he 52 mau pule. ʻO ka helu hope mua (ka hoʻololi i ka pruritus numerical rating scale score) a me ka lua hope (hoʻololi i ka helu ʻino ma ka Shiratori Severity Scale) ua hoʻomaikaʻi maikaʻi ʻia 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, a me ke kūlana hoʻomohala lāʻau i kēia manawa.