Kupita patsogolo kwa kafukufuku wama peptides opioid kuchokera kuvomerezedwa ndi Difelikefalin

Pofika chaka cha 2021-08-24, Cara Therapeutics ndi mnzake wa bizinesi Vifor Pharma adalengeza kuti kappa opioid receptor agonist difelikefalin (KORSUVA™) adavomerezedwa ndi FDA pochiza odwala matenda a impso (CKD) (Kupsa mtima Kwambiri/koopsa kokhala ndi chithandizo cha hemodialysis), ikuyembekezeka kukhazikitsidwa mu 2022Q1.Cara ndi Vifor anasaina pangano la laisensi yoti azigulitsa KORSUVA™ ku United States ndipo anavomera kugulitsa KORSUVA™ ku Fresenius Medical.Pakati pawo, Cara ndi Vifor aliyense ali ndi gawo la 60% ndi 40% la phindu lazogulitsa malonda kupatula Fresenius Medical;iliyonse ili ndi gawo la phindu la 50% pazogulitsa zogulitsa kuchokera ku Fresenius Medical.

CKD-Associated pruritus (CKD-aP) ndi pruritus yodziwika bwino yomwe imachitika pafupipafupi komanso mwamphamvu kwambiri mwa odwala CKD omwe akudwala dialysis.Pruritus imapezeka pafupifupi 60% -70% ya odwala omwe amalandila dialysis, pomwe 30% -40% amakhala ndi zotupa zapakatikati / zowopsa, zomwe zimakhudza kwambiri moyo wabwino (mwachitsanzo, kugona bwino) ndipo kumalumikizidwa ndi kukhumudwa.Palibe chithandizo chothandiza cha pruritus chokhudzana ndi CKD m'mbuyomu, ndipo kuvomerezedwa ndi Difelikefalin kumathandiza kuthana ndi vuto lalikulu lachipatala.Chivomerezochi chikuchokera pamayesero awiri ofunikira kwambiri a Phase III mu kusungitsa kwa NDA: zabwino zomwe zachokera ku mayeso a KALM-1 ndi KALM-2 ku US komanso padziko lonse lapansi, komanso chidziwitso chochokera ku maphunziro owonjezera 32 azachipatala, omwe akuwonetsa kuti KORSUVA ™ imalekerera bwino. .

Posachedwapa, uthenga wabwino unachokera ku kafukufuku wachipatala wa difelikefalin ku Japan: 2022-1-10, Cara adalengeza kuti anzake a Maruishi Pharma ndi Kissey Pharma adatsimikizira kuti jekeseni ya difelikefalin imagwiritsidwa ntchito ku Japan pochiza pruritus odwala hemodialysis.Mayesero achipatala a Gawo lachitatu Mapeto oyambirira adakwaniritsidwa.Odwala 178 adalandira milungu 6 ya difelikefalin kapena placebo ndipo adatenga nawo gawo pa kafukufuku wowonjezera wamasabata 52.Mapeto oyambirira (kusintha kwa pruritus chiwerengero cha chiwerengero cha chiwerengero cha chiwerengero) ndi mapeto achiwiri (kusintha kwa chiwerengero cha itch pa Shiratori Severity Scale) adasinthidwa kwambiri kuchokera pachiyambi mu gulu la difelikefalin poyerekeza ndi gulu la placebo ndipo analekerera bwino.

Difelikefalin ndi gulu la opioid peptides.Kutengera izi, Peptide Research Institute yaphunzira zolembedwa pa peptides ya opioid, ndikufotokozera mwachidule zovuta ndi njira za ma peptides a opioid pakukulitsa mankhwala, komanso momwe zinthu zilili panopa.