Iterambere ryubushakashatsi bwa peptide ya opioid bivuye kwa Difelikefalin

Nko mu 2021-08-24, Cara Therapeutics hamwe n’umufatanyabikorwa w’ubucuruzi Vifor Pharma batangaje ko icyiciro cya mbere cya kappa opioid reseptor agonist difelikefalin (KORSUVA ™) cyemejwe na FDA kuvura abarwayi b'impyiko zidakira (CKD). .Cara na Vifor basinye amasezerano yihariye yo kugurisha KORSUVA ™ muri Amerika kandi bemera kugurisha KORSUVA ™ kwa Fresenius Medical.Muri bo, Cara na Vifor buriwese 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 numuvuduko mwinshi nuburemere mubarwayi ba CKD barimo dialyse.Pruritus ibaho hafi 60% -70% byabarwayi bakira dialyse, muribo 30% -40% bafite pruritus iringaniye / ikabije, bigira ingaruka zikomeye kubuzima (urugero, gusinzira nabi) kandi bifitanye isano no kwiheba.Nta buryo bwiza bwo kuvura indwara ya CKD ifitanye isano na pruritus mbere, kandi kwemerwa na Difelikefalin bifasha gukemura icyuho kinini cyo gukenera ubuvuzi.Iki cyemezo gishingiye ku bigeragezo bibiri by'ingenzi byo mu cyiciro cya III cy’amavuriro mu itangwa rya NDA: amakuru meza yavuye mu bigeragezo bya KALM-1 na KALM-2 muri Amerika ndetse no ku isi yose, hamwe n’amakuru yunganira yavuye mu bushakashatsi 32 bw’ubuvuzi, bwerekana ko KORSUVA ™ yihanganira neza .

Vuba aha, inkuru nziza yavuye mubushakashatsi bwubuvuzi 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 mu barwayi ba hemodialyse.Icyiciro cya III cyamavuriro Ibizamini byanyuma byujujwe.Abarwayi 178 bakiriye ibyumweru 6 bya difelikefalin cyangwa placebo kandi bitabiriye ubushakashatsi bwagutse bwibyumweru 52.Iherezo ryibanze (impinduka muri pruritus numero yumubare wamanota) hamwe nuwanyuma (guhinduka mumanota ya itch kuri Shiratori Severity Scale) byatejwe imbere cyane uhereye kumurongo wo mumatsinda ya difelikefalin ugereranije nitsinda rya placebo kandi barihanganirwa neza.

Difelikefalin nicyiciro cya peptide ya opioid.Hashingiwe kuri ibi, Ikigo cy’ubushakashatsi cya Peptide cyize ku bitabo byerekeranye na peptide ya opioide, kandi kivuga muri make ingorane n’ingamba za peptide ya opioide mu iterambere ry’ibiyobyabwenge, ndetse n’ibihe bigenda bitera imbere.