I-PTSD: Uvavanyo lokuqala loNyango lwesigulana ngoku kuNyango lweMihla

I-JZP150 yanikwa ukutyunjwa kwe-Fast Track yi-US Food and Drug Administration (FDA) ye-PTSD ngokusekelwe kwimeko enzima ye-disorder. Ngokutsho kwe-FDA, oku kutyunjwa kwenzelwe ukuququzelela uphuhliso kunye nokukhawulezisa ukuphononongwa kwamayeza anyanga iimeko ezinzulu kwaye anamandla okujongana neemfuno zonyango ezingafezekanga.

"I-FDA's Fast Track ukutyunjwa kwe-JZP150 kukuqaphela okuphawulekayo kokubini, okuqhubekayo, iimfuno zonyango ezingafezekiyo zezigulane ze-PTSD kunye neenzuzo ezinokubakho ze-JZP150 yendlela yenoveli yokunyanga le ngxaki ephazamisayo," kusho uRob Iannone, MD, MSCE, usekela-mongameli olawulayo. , uphando kunye nophuhliso kunye negosa eliyintloko lezonyango kwiJazz Pharmaceuticals. "Umthwalo wesifo kwi-PTSD unokuba nefuthe elibi kwizigulana kunye neentsapho zabo kule meko iqhelekileyo apho kulindeleke ukuba ukunyuka kwande. IJazz izinikele ekuphuhliseni nasekuthengiseni amayeza amatsha kunye nokuqhubela phambili uphuhliso lwezonyango lwe-JZP150 sisiqalo sohambo olunentsingiselo lokunceda abantu abaphila ne-PTSD. "

I-PTSD yingxaki yengqondo echaphazela izigidi zabantu kunye nezigulane zihlala zineempawu ezingalawulekiyo ezichaphazela amandla abo okwenza imisebenzi yemihla ngemihla kunye nokusebenza koluntu. Okwangoku amayeza avunyiweyo akasebenzi kakuhle kwaye akukho nyango lukhoyo lwale meko. Zimbini kuphela ii-antidepressants ezifumene imvume kwi-FDA yonyango lweempawu ze-PTSD kwiminyaka engama-20 edlulileyo. Alukho unyango oluvunyiweyo olujolise kwibhayoloji esisiseko eguqula izehlo ezinxunguphalisayo kunye namava abe sisigulo esingapheliyo sempilo yengqondo yePTSD. 

“I-PTSD ibuchaphazela kakhulu ubomi, ubudlelwane kunye nemisebenzi yabantu abaphila nengxaki. Sifuna unyango olungcono ukuze sincede abo bonzakeleyo babuyisele ubomi babo,” utshilo uJohn H. Krystal, MD, uRobert L. McNeil Jr., unjingalwazi wophando loguqulo kunye nonjingalwazi wezengqondo, i-neuroscience, kunye nengqondo kwiYunivesithi yaseYale. "I-JZP150 ijolise kwindlela entsha engqondweni, kwaye olu lingo lutsha lweSigaba se-2 kwi-PTSD luya kusinceda ukuba sifunde ngakumbi malunga nokhuseleko lwemolekyuli kunye nokusebenza njengonyango olunokubakho kwizigulana ezinokuthi zixhamle kunyango lwenoveli."

Malunga neSigaba sesi-2 soLingo

I-multicenter, i-double-blind, i-randomized, isilingo sekliniki esilawulwa yi-placebo siya kuvavanya iidosi ezimbini ze-JZP150, kwaye iqhutywe kwiindawo zophononongo ze-40 zase-US. Ulingo luya kubhalisa abantu abadala abangama-270 abaneminyaka eyi-18 ukuya kwi-70 abafunyanwe bene-PTSD besebenzisa imigaqo ye-American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders, i-5th edition (DSM-5).

Isiphelo esiphambili sovavanyo silinganisa utshintsho lwabathathi-nxaxheba ukusuka kuphononongo luqale ukuya ekupheleni kwonyango usebenzisa amanqaku avela kwiKliniki-elawulwa yi-PTSD Scale (CAPS-5). I-CAPS-5 yinkqubo yodliwano-ndlebe yeklinikhi kwaye ithathwa njengomgangatho wegolide wokuxilonga nokuvavanya izigulane ezine-PTSD. Iquka izinto ze-30 apho oogqirha banokwenza ukuxilongwa kwe-PTSD kunye nokuvavanya ubunzima beempawu kunye nefuthe ekusebenzeni kwentlalo kunye nomsebenzi. Ulingo luneziphelo ezininzi zesibini, kubandakanywa utshintsho kumanqaku kwi-Clinical Global Impressions Severity kunye ne-Paent Global Impression ye-severity scales ukusuka ekuqaleni kophando ukuya ekupheleni kwonyango.              

Malunga neJZP150

I-JZP150 yi-molecule encinci yophando eyenzelwe ngokukhethekileyo ukuvimbela i-enzyme fatty acid amide hydrolase (FAAH) kwaye okwangoku kuphuhliso lonyango lwe-post-traumatic stress disorder (PTSD) kubantu abadala. Kwi-PTSD, iintsilelo zokuphela koloyiko zinegalelo ekuzinzeni kweenkumbulo ezibuhlungu. Amanyathelo okungenelela ukukhuthaza ukufunda ngokuphela koloyiko sisiseko sonyango lwe-PTSD. Unyango lwangoku lwangoku lokuqala lwe-pharmacological, olufana ne-serotonin reuptake inhibitors ekhethiweyo, ukunciphisa iimpawu ze-PTSD, kodwa ayenzelwanga ukulungisa ingxaki engundoqo (uloyiko lokufunda kunye nokudibanisa kwayo). Idatha evela kwizifundo zangaphambili zeklinikhi kunye nekliniki kunye ne-JZP150 zibonelela ubungqina bokuba i-FAAH inhibition inokuphucula ukukhunjulwa kweenkumbulo zokuphela koloyiko kunye nokunciphisa imiphumo ye-anxiogenic yoxinzelelo.

IJazz ifumene amalungelo ehlabathi jikelele kwi-JZP150, eyayifudula ibizwa ngokuba yi-PF-04457845, esuka kwi-SpringWorks Therapeutics ngo-Okthobha ka-2020. IPfizer Inc. yafumanisa kwaye yaphuhlisa imolekyuli yaza yanika imvume ekhethekileyo kwiSpringWorks.

Malunga ne-Post-Traumatic Stress Disorder

I-post-traumatic disorder disorder (PTSD) yimeko eqhelekileyo yengqondo enokuthi ibangele ngokuthe ngqo okanye ngokungathanga ngqo kwiziganeko ezibuhlungu kunye namava. Abantu abane-PTSD baneengcinga ezinzulu neziphazamisayo kunye neemvakalelo ezinxulumene namava abo aqhubeka ixesha elide emva kwesehlo esibuhlungu, kwaye banokusikhumbula eso siganeko ngokujonga izinto ezingalindelekanga okanye amaphupha amabi kwaye bazive lusizi, uloyiko, umsindo, kunye nokuzimela kwabanye abantu. Umthwalo we-PTSD mkhulu kakhulu kunye nezigulana ezizama ukulawula iimpawu zazo, ukwenza imisebenzi yemihla ngemihla kunye nokusebenza ngokwentlalo. Kukho isidingo esibalulekileyo esingafezekiswanga kwizigulana ezine-PTSD njengoko kungekho nyango lunyanga unobangela wokuphazamiseka.