PTSD: Kuyesa Kwachipatala Koyamba Kwa Odwala Tsopano Kwa Chithandizo Cha kamodzi Tsiku ndi Tsiku

JZP150 inapatsidwa dzina la Fast Track ndi US Food and Drug Administration (FDA) kwa PTSD malinga ndi vuto lalikulu la matendawa. Malinga ndi a FDA, kutchulidwa uku ndi cholinga chothandizira chitukuko ndikufulumizitsa kuunikanso kwamankhwala omwe amachiza matenda oopsa komanso omwe angathe kuthana ndi zosowa zachipatala zomwe sizinakwaniritsidwe.

"Matchulidwe a FDA's Fast Track a JZP150 ndikuzindikira kofunikira kwa odwala omwe ali ndi PTSD, omwe akupitilirabe, osakwaniritsa komanso phindu lomwe lingakhalepo mu njira yatsopano ya JZP150 yochizira matendawa," adatero Rob Iannone, MD, MSCE, wachiwiri kwa purezidenti. , kafukufuku ndi chitukuko ndi mkulu wachipatala wa Jazz Pharmaceuticals. "Kulemetsa kwa matenda a PTSD kumatha kukhala ndi vuto lalikulu kwa odwala ndi mabanja awo chifukwa cha zomwe zimachitika zomwe zikuyembekezeka kuchuluka. Jazz idadzipereka kupanga ndi kugulitsa mankhwala opangidwa mwaluso komanso kupititsa patsogolo chitukuko cha JZP150 ndiye chiyambi chaulendo wothandiza anthu omwe ali ndi PTSD. "

PTSD ndi matenda amisala omwe amakhudza anthu mamiliyoni ambiri ndipo odwala nthawi zambiri amakhala ndi zizindikiro zosalamulirika zomwe zimakhudza kuthekera kwawo kuchita zinthu zatsiku ndi tsiku ndikugwira ntchito momasuka. Panopa mankhwala ovomerezeka ali ndi mphamvu zochepa ndipo palibe mankhwala omwe alipo. Odwala awiri okha omwe adalandira chilolezo kuchokera ku FDA kuti athe kuchiza zizindikiro za PTSD m'zaka 20 zapitazi. Palibe njira zochiritsira zovomerezeka zomwe zimayang'ana pa biology yomwe imasintha zochitika zowawa ngati izi kukhala matenda osatha amisala a PTSD. 

"PTSD imakhudza kwambiri miyoyo, maubwenzi ndi ntchito za anthu omwe ali ndi vutoli. Timafunikira chithandizo chabwinoko kuti tithandize anthu ovutika maganizo kuti apezenso miyoyo yawo,” anatero John H. Krystal, MD, Robert L. McNeil Jr., pulofesa wa kafukufuku womasulira komanso pulofesa wa zamaganizo, sayansi ya ubongo, ndi maganizo pa yunivesite ya Yale. "JZP150 imayang'ana njira yatsopano muubongo, ndipo kuyesa kwa Gawo 2 kwa PTSD kudzatithandiza kuphunzira zambiri za chitetezo ndi mphamvu ya molekyulu ngati chithandizo chotheka kwa odwala omwe angapindule ndi chithandizo chamakono."

Pazoyeserera za Phase 2

Mayesero achipatala opangidwa ndi ma multicenter, awiri akhungu, osasinthika, oyendetsedwa ndi placebo adzayesa milingo iwiri ya JZP150, ndipo ikuchitika m'malo ophunzirira a 40 US. Mlanduwu udzalembetsa akuluakulu 270 azaka zapakati pa 18 mpaka 70 omwe adapezeka ndi PTSD pogwiritsa ntchito ndondomeko ya American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5).

Mapeto oyambirira a mayeserowa amayesa kusintha kwa omwe akutenga nawo mbali kuchokera ku phunziroli mpaka kumapeto kwa chithandizo pogwiritsa ntchito mapepala ochokera ku Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 ndi kuyankhulana kwachipatala komwe kumapangidwa ndipo kumawerengedwa kuti ndi muyezo wagolide wowunikira ndikuwunika odwala omwe ali ndi PTSD. Zimaphatikizapo zinthu 30 zomwe madokotala amatha kupanga matenda a PTSD ndikuwunika kuopsa kwa zizindikiro komanso momwe zimakhudzira chikhalidwe ndi ntchito. Mlanduwu uli ndi mapeto angapo achiwiri, kuphatikizapo kusintha kwa ziwerengero pa Clinical Global Impressions Severity ndi Patient Global Impression of severity scales kuyambira pachiyambi mpaka kumapeto kwa chithandizo.              

Zithunzi za JZP150

JZP150 ndi molekyu yaing'ono yofufuza yomwe imapangidwira kuti iwononge enzyme fatty acid amide hydrolase (FAAH) ndipo pakali pano ikukonzekera chithandizo cha post-traumatic stress disorder (PTSD) mwa akuluakulu. Mu PTSD, kuchepa kwa mantha kumapangitsa kuti pakhale kukumbukira zowawa. Njira zolimbikitsira kuphunzira kutha kwa mantha ndiye maziko a chithandizo cha PTSD. Thandizo lamakono lamakono lamankhwala, monga kusankha serotonin reuptake inhibitors, kuchepetsa zizindikiro za PTSD, koma sizinapangidwe kuti zithetse vuto lalikulu (kuopa kutha kwa kuphunzira ndi kuphatikizika kwake). Deta yochokera m'maphunziro am'mbuyomu komanso azachipatala ndi JZP150 imapereka umboni woti kuletsa kwa FAAH kumathandizira kukumbukira kukumbukira kutha kwa mantha ndikuchepetsa kupsinjika kwa nkhawa.

Jazz idapeza ufulu wapadziko lonse ku JZP150, yomwe kale inkadziwika kuti PF-04457845, kuchokera ku SpringWorks Therapeutics mu Okutobala 2020. Pfizer Inc. poyambirira idapeza ndikupanga molekyuluyo ndikuipatsa chilolezo ku SpringWorks.

About Post-Traumatic Stress Disorder

Matenda a post-traumatic stress disorder (PTSD) ndi matenda amisala omwe amabwera chifukwa chokumana ndi zochitika zowawa komanso zowawa. Anthu omwe ali ndi PTSD amakhala ndi malingaliro ozama komanso okhumudwitsa okhudzana ndi zomwe adakumana nazo zomwe zimapitilira nthawi yayitali pambuyo pa zomwe zidawachitikira, ndipo amatha kukumbukira zomwe zidachitikazo kudzera muzongopeka kapena maloto owopsa ndikumva chisoni, mantha, mkwiyo, ndi kudzipatula kwa anthu ena. Cholemetsa cha PTSD ndi chachikulu ndi odwala omwe akuvutika kuti athe kuwongolera zizindikiro zawo, kuchita zinthu zatsiku ndi tsiku ndikugwira ntchito momasuka. Pali kufunikira kosakwanira kwa odwala omwe ali ndi PTSD chifukwa palibe mankhwala omwe amathandizira chomwe chimayambitsa vutoli.