N'ihe dị ka 2021-08-24, Cara Therapeutics na onye ya na ya na-azụ ahịa Vifor Pharma kwupụtara na FDA kwadoro ya na klas mbụ kappa opioid receptor agonist difelikefalin (KORSUVA™) maka ọgwụgwọ nke ọrịa akụrụ na-adịghị ala ala (CKD) ndị ọrịa (ezigbo Moderate / siri ike itching na hemodialysis na-atụ anya ka a gwọọ ya). Cara na Vifor bịanyere aka na nkwekọrịta ikike pụrụiche maka azụmahịa nke KORSUVA™ na United States wee kwenye ire KORSUVA™ na Fresenius Medical. N'ime ha, Cara na Vifor nke ọ bụla nwere 60% na 40% uru uru na ego ahịa ndị ọzọ karịa Fresenius Medical; Onye ọ bụla nwere oke uru 50% na ego ọrịre site na Fresenius Medical.
CKD-ejikọtara pruritus (CKD-aP) bụ ọzịza a na-ahụkarị nke na-eme n'ọtụtụ ugboro yana ike n'ime ndị ọrịa CKD na-enweta dialysis. Pruritus na-apụta n'ihe dịka 60%-70% nke ndị ọrịa na-anata dialysis, nke 30%-40% nwere oke itching/oke itching, nke na-emetụta oke ndụ ndụ (dịka ọmụmaatụ, ụra adịghị mma) yana jikọtara ya na ịda mbà n'obi. Enweghị ọgwụgwọ dị irè maka itching metụtara CKD na mbụ, na nkwenye nke Difelikefalin na-enyere aka dozie nnukwu ọdịiche dị mkpa ahụike. Nkwenye a dabere na nnwale ụlọ ọgwụ abụọ dị mkpa na Phase III na ntinye akwụkwọ NDA: data dị mma sitere na nnwale KALM-1 na KALM-2 na US na ụwa niile, yana data nkwado sitere na ọmụmụ ụlọ ọgwụ 32 ọzọ, nke gosipụtara na KORSUVA ™ nabatara nke ọma.
N'oge na-adịbeghị anya, ozi ọma sitere na nyocha ụlọ ọgwụ nke difelikefalin na Japan: 2022-1-10, Cara kwupụtara na ndị mmekọ ya Maruishi Pharma na Kissey Pharma kwadoro na a na-eji ọgwụ mgbochi difelikefalin na Japan maka ọgwụgwọ itching na ndị ọrịa hemodialysis. Nnwale ụlọọgwụ nke Atọ ka ezutere isi njedebe ikpeazụ. Ndị ọrịa 178 natara izu isii nke difelikefalin ma ọ bụ placebo ma sonye na ọmụmụ mgbatị oghere 52 izu. Isi njedebe (mgbanwe na akara ọnụọgụ ọnụọgụ pruritus) na njedebe nke abụọ (mgbanwe na akara ich na Shiratori Severity Scale) ka emelitere nke ọma site na ntọala n'ime otu difelikefalin ma e jiri ya tụnyere ndị otu placebo ma nabata ya nke ọma.
Difelikefalin bụ klas nke peptides opioid. Dabere na nke a, Peptide Research Institute amụwo akwụkwọ gbasara peptides opioid, ma chịkọta ihe isi ike na atụmatụ nke peptides opioid na mmepe ọgwụ, yana ọnọdụ mmepe ọgwụ ugbu a.
Oge nzipu: Feb-17-2022

