I-PTSD: Isivivinyo Somtholampilo Sokuqala Esisesigulini Manje Sokwelashwa Kwakanye Kwansuku zonke

I-JZP150 yanikezwa ukuqokwa kwe-Fast Track yi-US Food and Drug Administration (FDA) ye-PTSD ngokusekelwe esimweni esibucayi salesi sifo. Ngokusho kwe-FDA, lokhu kuqokwa kuhloselwe ukusiza ukuthuthukiswa nokusheshisa ukubuyekezwa kwemithi elapha izimo ezibucayi futhi enamandla okubhekana nezidingo zezokwelapha ezingahlangatsheziwe.

"Ukuqokwa kwe-FDA's Fast Track ye-JZP150 kuwukuqashelwa okuphawulekayo kokubili kwezidingo zezokwelapha ezinzima, eziqhubekayo, ezingahlangatshezwana ne-PTSD kanye nezinzuzo ezingaba khona zendlela yenoveli ye-JZP150 yokwelapha lesi sifo esiwohlozayo," kusho u-Rob Iannone, MD, MSCE, iphini likamongameli omkhulu. , ucwaningo nentuthuko kanye nesikhulu sezokwelapha se-Jazz Pharmaceuticals. “Umthwalo wesifo ku-PTSD ungaba nomthelela omubi ezigulini nasemindenini yazo ngenxa yalesi simo esijwayelekile lapho kulindeleke ukuthi ukwanda kwande. I-Jazz izinikele ekuthuthukiseni nasekuthengiseni imithi emisha kanye nokuqhubekisela phambili ukuthuthukiswa komtholampilo kwe-JZP150 kuyisiqalo sohambo olunenjongo lokusiza abantu abaphila ne-PTSD.”

I-PTSD isifo sengqondo esithinta izigidi zabantu futhi iziguli zivame ukuba nezimpawu ezingalawuleki ezithinta ikhono lazo lokwenza imisebenzi yansuku zonke nokusebenza komphakathi. Imithi egunyaziwe njengamanje isebenza ngokulinganiselwe futhi alikho ikhambi elitholakalayo lalesi simo. Ama-antidepressants amabili kuphela athole imvume evela ku-FDA yokwelashwa kwezimpawu ze-PTSD eminyakeni engama-20 edlule. Azikho izindlela zokwelapha ezigunyaziwe eziqondise kubhayoloji ewumsuka eguqula izehlakalo ezibuhlungu kanjalo nezehlakalo zibe yisifo esingelapheki sempilo yengqondo ye-PTSD. 

“I-PTSD ithinta kakhulu izimpilo, ubudlelwano kanye nemisebenzi yabantu abaphila nalesi sifo. Sidinga ukwelashwa okungcono ukuze sisize labo abahlukumezekile babuyisele ukuphila kwabo,” kusho uJohn H. Krystal, MD, Robert L. McNeil Jr., uprofesa wocwaningo lokuhumusha kanye noprofesa wezifo zengqondo, i-neuroscience, kanye nengqondo eYunivesithi yaseYale. "I-JZP150 iqondise indlela entsha esengqondweni, futhi lolu cwaningo olusha lweSigaba 2 ku-PTSD luzosisiza ukuthi sifunde kabanzi ngokuphepha nokusebenza kwe-molecule njengendlela yokwelapha engaba khona ezigulini ezingazuza ekwelashweni kwenoveli."

Mayelana Nesivivinyo Sesigaba sesi-2

Uhlolo lomtholampilo olugxile ezindaweni eziningi, olungaboni kabili, olungahleliwe, olulawulwa yi-placebo luzohlola imithamo emibili ye-JZP150, futhi lwenziwa kuzo zonke izizinda zocwaningo zase-US ezingama-40. Ukuhlolwa kuzobhalisa abantu abadala abangu-270 abaneminyaka engu-18 kuya kwengama-70 abatholakale bene-PTSD kusetshenziswa indlela yokunquma ye-American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders, uhlelo lwesi-5 (DSM-5).

Isiphetho esiyinhloko socwaningo sikala izinguquko zabahlanganyeli kusukela ekuqaleni kocwaningo kuya ekupheleni kokwelashwa kusetshenziswa amaphuzu asuka ku-Clinical-Administered PTSD Scale (CAPS-5). I-CAPS-5 iyinhlolokhono yomtholampilo ehlelekile futhi ibhekwa njengezinga legolide lokuxilonga nokuhlola iziguli ezine-PTSD. Kuhlanganisa izinto ezingu-30 odokotela abangenza ngazo ukuxilonga i-PTSD futhi bahlole ukuqina kwezimpawu kanye nomthelela ekusebenzeni komphakathi nomsebenzi. Uhlolo luneziphetho ezimbalwa zesibili, okuhlanganisa izinguquko kuzikolo ze-Clinical Global Impressions Severity kanye ne-Patient Global Impression yezilinganiso zobunzima kusukela ekuqaleni kocwaningo kuya ekupheleni kokwelashwa.              

Mayelana ne-JZP150

I-JZP150 iyi-molecule encane yophenyo eyenzelwe ukuvimbela ngokukhetha i-enzyme fatty acid amide hydrolase (FAAH) futhi okwamanje ithuthukiswe ukwelashwa kwe-post-traumatic stress disorder (PTSD) kubantu abadala. Ku-PTSD, ukushoda kokushabalala kokwesaba kunomthelela ekuphikeleleni kwezinkumbulo ezibuhlungu. Ukungenelela okugqugquzela ukufunda ngokushabalala kokwesaba kuyisisekelo sokwelashwa kwe-PTSD. Imithi yokwelapha yomugqa wokuqala yamanje, njenge-serotonin reuptake inhibitors ekhethiwe, inciphisa ezinye izimpawu ze-PTSD, kodwa ayakhelwe ukubhekana nenkinga ewumgogodla (ukufunda ngokushabalala kokwesaba nokuhlanganiswa kwayo). Idatha evela ezifundweni zangaphambilini ze-preclinical kanye nekliniki nge-JZP150 inikeza ubufakazi bokuthi ukuvimbela i-FAAH kungathuthukisa ukukhunjulwa kwezinkumbulo zokuqothulwa kokwesaba futhi kunciphise imiphumela yokukhathazeka yokucindezeleka.

I-Jazz ithole amalungelo omhlaba wonke e-JZP150, ngaphambilini ebibizwa nge-PF-04457845, kwa-SpringWorks Therapeutics ngo-Okthoba 2020. I-Pfizer Inc. yaqala yathola futhi yathuthukisa i-molecule futhi yayinika ilayisensi ngokukhethekile kwa-SpringWorks.

Mayelana Ne-Post-Traumatic Stress Disorder

I-post-traumatic stress disorder (PTSD) yisimo sengqondo esivamile esingaba umphumela wokuchayeka ngokuqondile noma ngokungaqondile ezehlakalweni ezibuhlungu kanye nokuhlangenwe nakho. Abantu abane-PTSD banemicabango nemizwa ejulile nephazamisayo ehlobene nolwazi lwabo oluphikelela isikhathi eside ngemva kwesigameko sabo esibuhlungu, futhi bangase baphinde basikhumbule lesi sigameko ngokukhumbula okwenzeka emuva noma amaphupho amabi futhi bezwe ukudabuka, ukwesaba, intukuthelo, nokuhlukana nabanye abantu. Umthwalo we-PTSD mkhulu kakhulu ngeziguli ezilwela ukulawula izimpawu zazo, ukwenza imisebenzi yansuku zonke kanye nokusebenza komphakathi. Kunesidingo esibalulekile esingafezeki seziguli ezine-PTSD njengoba lungekho ukwelapha okwelapha umsuka walesi sifo.