Iterambere ryubushakashatsi bwa peptide ya opioid uhereye kubyemejwe na Difelikefalin

Nko mu 2021-08-24, Cara Therapeutics hamwe n’umufatanyabikorwa w’ubucuruzi Vifor Pharma batangaje ko icyiciro cyayo cya mbere mu cyiciro cya mbere cya kappa opioid reseptor agonist difelikefalin (KORSUVA ™) cyemejwe na FDA yo kuvura indwara z’impyiko zidakira (CKD) (biteganijwe ko zishyirwa mu bikorwa 20). Cara na Vifor basinyanye amasezerano yihariye yo kugurisha KORSUVA ™ muri Amerika kandi bemera kugurisha KORSUVA ™ kwa Fresenius Medical. Muri bo, Cara na Vifor buri wese afite 60% na 40% byinyungu byinjira mubicuruzwa bitari Ubuvuzi bwa Fresenius; buriwese afite umugabane winyungu 50% mumafaranga yagurishijwe ava mubuvuzi bwa Fresenius.

Indwara ya CKD ifitanye isano na pruritus (CKD-aP) ni pruritus rusange ibaho hamwe numurongo mwinshi nuburemere kubarwayi ba CKD barimo dialyse. Pruritus ibaho hafi 60% -70% by'abarwayi bakira dialyse, muri bo 30% -40% bafite pruritus igereranije / ikabije, bigira ingaruka zikomeye ku mibereho (urugero, gusinzira nabi) kandi bifitanye isano no kwiheba. Nta muti ufatika wa pruritus ujyanye na CKD mbere, kandi kwemerwa na Difelikefalin bifasha gukemura icyuho kinini gikenewe mubuvuzi. Iki cyemezo gishingiye ku manza ebyiri zingenzi z’icyiciro cya gatatu cy’amavuriro mu itangwa rya NDA: amakuru meza yavuye mu manza za KALM-1 na KALM-2 muri Amerika ndetse no ku isi yose, hamwe n’amakuru ashyigikira ubushakashatsi 32 bw’ubuvuzi bw’inyongera, bwerekana ko KORSUVA ™ yihanganira neza.

Vuba aha, inkuru nziza yavuye mu bushakashatsi bw’ubuvuzi bwa difelikefalin mu Buyapani: 2022-1-10, Cara yatangaje ko abafatanyabikorwa bayo Maruishi Pharma na Kissey Pharma bemeje ko inshinge za difelikefalin zikoreshwa mu Buyapani mu kuvura pruritus ku barwayi ba hemodialyse. Icyiciro cya III ibizamini byamavuriro Iherezo ryibanze ryujujwe. Abarwayi 178 bakiriye ibyumweru 6 bya difelikefalin cyangwa placebo kandi bitabiriye ubushakashatsi bwagutse bwibyumweru 52. Iherezo ryibanze (impinduka muri pruritus numero yumubare wamanota amanota) hamwe nicyiciro cya kabiri (guhindura amanota ya itch ku gipimo cya Shiratori Severity Scale) byatejwe imbere cyane uhereye kumurongo wo mumatsinda ya difelikefalin ugereranije nitsinda rya placebo kandi barihanganirwa.

Difelikefalin ni urwego rwa peptide ya opioid. Hashingiwe kuri ibi, Ikigo cy’ubushakashatsi cya Peptide cyize ku bitabo byerekeranye na peptide ya opioide, inagaragaza muri make ingorane n’ingamba za peptide ya opioide mu iterambere ry’ibiyobyabwenge, ndetse n’iterambere ry’ibiyobyabwenge muri iki gihe.