Ci gaban bincike na peptides na opioid daga amincewar Difelikefalin

Tun daga 2021-08-24, Cara Therapeutics da abokin kasuwancinsa Vifor Pharma sun ba da sanarwar cewa kappa opioid receptor agonist difelikefalin (KORSUVA™) ya sami amincewar FDA don kula da marasa lafiya na koda na kullum (CKD). (tabbataccen Matsakaici/mai tsanani pruritus tare da maganin hemodialysis), ana sa ran kaddamar da shi a cikin 2022Q1.Cara da Vifor sun rattaba hannu kan yarjejeniyar lasisi ta keɓance don siyar da KORSUVA™ a cikin Amurka kuma sun amince su sayar da KORSUVA™ ga Fresenius Medical.Daga cikin su, Cara da Vifor kowanne yana da kashi 60% da 40% riba a cikin kudaden tallace-tallace ban da Fresenius Medical;kowanne yana da kashi 50% na riba a cikin kudaden tallace-tallace daga Fresenius Medical.

CKD-associated pruritus (CKD-aP) wani kumburi ne na gabaɗaya wanda ke faruwa tare da yawan mita da ƙarfi a cikin marasa lafiya na CKD da ke jurewa dialysis.Pruritus yana faruwa a cikin kusan 60% -70% na marasa lafiya da ke karɓar dialysis, wanda 30% -40% suna da matsakaici / matsananciyar pruritus, wanda ke da matukar tasiri ga ingancin rayuwa (misali, rashin ingancin bacci) kuma yana da alaƙa da baƙin ciki.Babu wani ingantaccen magani ga CKD da ke da alaƙa da pruritus a baya, kuma amincewar Difelikefalin yana taimakawa wajen magance babban gibin buƙatar likita.Wannan amincewa ya dogara ne akan gwaje-gwajen asibiti na Phase III guda biyu a cikin shigar da NDA: ingantattun bayanai daga gwajin KALM-1 da KALM-2 a cikin Amurka da na duniya, da bayanan tallafi daga ƙarin ƙarin karatun asibiti na 32, waɗanda ke nuna cewa KORSUVA ™ sun yi haƙuri sosai. .

Ba da dadewa ba, labari mai daɗi ya fito daga binciken asibiti na difelikefalin a Japan: 2022-1-10, Cara ta sanar da cewa abokan haɗin gwiwarta Maruishi Pharma da Kissey Pharma sun tabbatar da cewa ana amfani da allurar difelikefalin a Japan don maganin pruritus a cikin marasa lafiya na hemodialysis.Gwajin gwaji na asibiti na Mataki na III An cimma maƙasudin ƙarshen farko.Marasa lafiya 178 sun sami makonni 6 na difelikefalin ko placebo kuma sun shiga cikin binciken tsawaita alamar budaddiyar mako na 52.Matsayin ƙarshe na farko (canji a ma'aunin ƙimar ƙima na pruritus) da na biyu na ƙarshe (canjin ƙima akan ma'aunin ƙaiƙayi na Shiratori Scale) an inganta sosai daga tushe a cikin rukunin difelikefalin idan aka kwatanta da ƙungiyar placebo kuma an jure su da kyau.

Difelikefalin aji ne na peptides na opioid.Bisa ga wannan, Cibiyar Bincike ta Peptide ta yi nazarin wallafe-wallafe game da peptides na opioid, kuma ta taƙaita matsaloli da dabarun maganin peptides na opioid a cikin ci gaban ƙwayoyi, da kuma halin da ake ciki na ci gaban ƙwayoyi.