JZP150 yakapiwa Fast Track kusarudzwa neU.S. Food and Drug Administration (FDA) yePTSD zvichienderana nehupamhi hwechirwere. Sekureva kweFDA, kudomwa uku kunoitirwa kufambisa budiriro uye nekukasira ongororo yemishonga inorapa zvakakomba uye ine mukana wekugadzirisa izvo zvisina kuzadziswa zvinodiwa pakurapa.
"FDA's Fast Track kudomwa kweJZP150 kucherechedzwa kunozivikanwa kwezvose zviri zviviri zvakakomba, zvinoramba zvichiitika, zvisingazadziswe zvinodiwa zvekurapa zvevarwere vePTSD uye mabhenefiti angangoita eJZP150's nzira itsva yekurapa chirwere ichi chinopedza simba," akadaro Rob Iannone, M.D., M.S.C.E., mutevedzeri wemutungamiri mukuru. , kutsvagisa nekusimudzira uye mukuru wezvekurapa weJazz Pharmaceuticals. "Chirwere chinoremerwa nePTSD chinogona kukanganisa varwere nemhuri dzavo nekuda kwechiitiko ichi chakajairika uko kuwanda kunotarisirwa kuwedzera. Jazz yakatsaurirwa kugadzira nekutengesa mishonga yemhando yepamusoro uye kufambira mberi kwekiriniki yeJZP150 ndiko kutanga kwerwendo rune musoro kubatsira vanhu vanorarama nePTSD. "
PTSD chirwere chepfungwa chinokanganisa mamiriyoni evanhu uye varwere vanowanzova nezviratidzo zvisingadzoreki zvinokanganisa kukwanisa kwavo kuita mabasa ehupenyu hwezuva nezuva nekushanda munharaunda. Parizvino mishonga yakatenderwa haishande uye hapana mushonga uripo. Vaviri chete vanodzvinyirira vakagamuchira mvumo kubva kuFDA yekurapa zviratidzo zvePTSD mumakore makumi maviri apfuura. Hapana marapiro anotenderwa anonangana neiyo biology inoshandura zviitiko zvinoshungurudza zvakadaro uye zviitiko kuita chirwere chisingaperi chehutano hwepfungwa chePTSD.
"PTSD inokanganisa zvakanyanya hupenyu, hukama uye mabasa evanhu vanorarama nechirwere ichi. Tinoda marapirwo ari nani kubatsira avo vakakuvadzwa mupfungwa kuti vawanezve upenyu hwavo,” akadaro John H. Krystal, M.D., Robert L. McNeil Jr., purofesa wetsvakurudzo yeshanduro uye purofesa wepfungwa, neuroscience, uye psychology paYale University. "JZP150 inotarisa nzira itsva muuropi, uye iyi itsva Phase 2 muedzo muPTSD ichatibatsira kudzidza zvakawanda pamusoro pekuchengetedzwa kwemorekuru uye kushanda kwayo senzira inogona kurapwa kune varwere vaizobatsirwa nerutsva rutsva."
Nezve Phase 2 Muedzo
Muyedzo wekiriniki wakawanda, wakapetwa kaviri, wakasarudzika, unodzorwa ne placebo uchaongorora madosi maviri eJZP150, uye uri kuitwa munzvimbo dze40 dzeU.S. Muedzo uchanyoresa vanhu vakuru mazana maviri nemakumi manomwe vane makore gumi nemasere kusvika makumi manomwe vakawanikwa vaine PTSD vachishandisa nzira yeAmerican Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders, 270th edition (DSM-18).
Mhedzisiro yekutanga yekuedza inoyera kuchinja kwevatori vechikamu kubva pakudzidza kusvika kumagumo ekurapa vachishandisa mucherechedzo kubva kuClinian-Administered PTSD Scale (CAPS-5). CAPS-5 yakarongeka kubvunzurudza kwekiriniki uye inoonekwa seyegoridhe chiyero chekuongorora uye kuongorora varwere vane PTSD. Inosanganisira zvinhu makumi matatu izvo vanachiremba vanogona kuita kuti PTSD iongorore uye kuongorora kuoma kwezviratidzo pamwe nekukanganisa kwekushanda kwevanhu uye basa. Muedzo wacho une magumo echipiri echipiri, kusanganisira kuchinja kwezvibodzwa paClinical Global Impressions Severity uye Patient Global Impression yezvikero zvekuoma kubva pakudzidza kusvika kumagumo ekurapwa.
Pamusoro peJZP150
JZP150 inotsvakurudza mamorekuru maduku akaumbwa kuti asarudze inhibit enzyme fatty acid amide hydrolase (FAAH) uye iye zvino ari mukugadzirwa kwekurapa kwe-post-traumatic stress disorder (PTSD) muvanhu vakuru. MuPTSD, kutya kupera kushomeka kunobatsira pakuramba kwendangariro dzinoshungurudza. Kupindira kwekusimudzira kutya kupera kudzidza ndiyo hwaro hwekurapwa kwePTSD. Ikozvino mutsara wekutanga wemishonga yemishonga, yakadai sekusarudza serotonin reuptake inhibitors, kuderedza zvimwe zviratidzo zvePTSD, asi hazvina kugadzirirwa kugadzirisa dambudziko guru (kutya kupera kudzidza uye kubatanidzwa kwayo). Dhiyabhorosi kubva kune zvidzidzo zvekare zvekare uye zvekliniki neJZP150 zvinopa uchapupu hwokuti FAAH inhibition inogona kuvandudza chiyeuchidzo chekutya kupera kwendangariro uye kuderedza migumisiro ye anxiogenic yekushungurudzika.
Jazz yakawana kodzero dzepasi rose kuJZP150, yaimbonzi PF-04457845, kubva kuSpringWorks Therapeutics muna Gumiguru 2020. Pfizer Inc. yakatanga kuwana ndokugadzira morekuru ndokuripa rezenisi kuSpringWorks.
NezvePost-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) inowanzoitika mupfungwa iyo inogona kuguma kubva kune zvakananga kana kuti zvisina kunanga kuratidzwa kwezviitiko zvinoshungurudza uye zvakaitika. Vanhu vane PTSD vane pfungwa dzakasimba uye dzinovhiringidza uye manzwiro ane chokuita nechiitiko chavo chinopfuurira kwenguva refu mushure mechiitiko chavo chinoshungurudza, uye vanogona kudzokorora chiitiko kuburikidza nekudzoka shure kana kurota zvinotyisa uye kunzwa kusuruvara, kutya, kutsamwa, uye kushamwaridzana kubva kune vamwe vanhu. Mutoro wePTSD wakakura nevarwere vari kunetseka kudzora zviratidzo zvavo, kuita zviitiko zvezuva nezuva uye kushanda munharaunda. Pane kudikanwa kusingakwane kwevarwere vane PTSD sezvo pasina marapirwo anobata honzeri yechirwere ichi.
ZVOKUBVA MUNYAYA INO:
- “JZP150 targets a novel mechanism in the brain, and this new Phase 2 trial in PTSD will help us to learn more about the molecule’s safety and effectiveness as a potential treatment for patients who would benefit from a novel therapy.
- Jazz is dedicated to developing and commercializing innovative medicines and progressing the clinical development of JZP150 is the start to a meaningful journey to help people living with PTSD.
- “FDA’s Fast Track designation of JZP150 is a notable recognition of both the serious, ongoing, unmet medical needs of PTSD patients and the potential benefits of JZP150’s novel mechanism to treat this debilitating disorder,”.
