Chirevo Chitsva cheHusiku Zviratidzo uye Kwemasikati Kushanda muVakuru vane Insomnia

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Idorsia Pharmaceuticals, US Inc. nhasi yakazivisa kubudiswa kwe "Kuchengeteka uye kushanda kwe daridoexant kune varwere vane chirwere chekushaya hope: migumisiro kubva kune maviri multicenter, randomized, double-blind, placebo-controlled, phase 3 miedzo" muThe Lancet Neurology.

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Daridorexant 25 mg uye 50 mg yakavandudza kurara kwemigumisiro, uye daridorexant 50 mg yakavandudzawo kushanda kwemasikati, muvanhu vane chirwere chekushaya hope, vane hutano hwakanaka hwekuchengetedza. Chiitiko chese chezviitiko zvakashata chakaenzaniswa pakati pemapoka ekurapa muvakuru nevakuru vakuru (vane makore 65 uye kupfuura) vane kushaya hope. Sezvakataurwa, daridoexant 50 mg yakaratidza kuvandudzwa kwehuwandu mumagumo ekutanga ekurara kwekutanga nekugadzirisa pamwe chete nemagumo ekupedzisira ekurara nguva yose uye kurara kwemasikati.

Zvinonyanya kukosha, miedzo ndiyo yekutanga kuongorora mhedzisiro yekurapa kwekurara pakushanda kwemasikati, uchishandisa yakagadziriswa-yakashumwa nemurwere mhedzisiro chishandiso, iyo inosanganisira matatu akasiyana domains (yambiro / cognition, manzwiro, uye kurara). Daridorexant 50 mg, iyo yakaongororwa mune imwe yezviedzo zviviri, yakaratidza kuvandudzwa kana ichienzaniswa neyokutanga kumativi ose emasikati ekushanda domains ane yakakwirira yehutano.

Emmanuel Mignot, MD, Purofesa wePsychiatry uye Behavioral Sayenzi paStanford University uye munyori anotungamira, akati:

“Vanhu vane kushaya hope vanowanzochema-chema nekusashanda zvakanaka masikati. Iyi inyaya hombe inowanzo furatirwa mukurapa kushaya hope uye chokwadi zvinodhaka zvakawanda zvinokurudzira kurara zvinogona kukanganisa kushanda kwemasikati kana zvine zvasara. Muchirongwa ichi, hatina kungoona kushanda kwe daridorexant pakurara induction, kuchengetedza uye kutaurwa kwemurwere-huwandu hwekurara uye hutano, asi zvakakosha, pachiyero che50 mg, pakushanda kwemasikati, kunyanya munharaunda yekurara sezvakayerwa nehutsva. chikero, iyo IDSIQ. Vatori vechikamu muboka re daridorexant 50 mg vakashuma kuvandudzwa mune dzakawanda zvikamu zvekushanda kwemasikati, sezvakaongororwa nechimbo ichi chitsva uye chakasimbiswa chakaongorora mafungiro, kusvinura / cognition, uye kurara. Zvinofadza kuona kuti kushaya hope hakungoonekwi sechinetso cheusiku chete asi sechikonzero chokutambura masikati.”

Efficacy uye Chengetedzo Migumisiro

Daridorexant 50 mg yakanyatsovandudza kurara kwekutanga, kuchengetedza kurara uye kuzvitaurira nguva yose yekurara mumwedzi mumwe nemitatu kana ichienzaniswa ne placebo. Mhedzisiro yakakura yakaonekwa neiyo yakanyanya dhigirii (50 mg), ichiteverwa ne25 mg, nepo 10 mg dosi haina kuita yakakosha. Mumapoka ose ekurapa kuwanda kwematanho ekurara kwakachengetedzwa, kusiyana nezvakawanikwa zvakataurwa ne benzodiazepine receptor agonists.

Chinhu chikuru chekuedza kwaiva kuongorora kukanganisa kwe daridoexant pakushanda kwemasikati kune varwere vane kushaya hope, sezvakaongororwa neInsomnia Daytime Symptoms uye Impacts Questionnaire (IDSIQ). IDSIQ chigadziriso chemurwere-chakashumwa mhedzisiro chimbo chakanyatsogadzirwa maererano neFDA nhungamiro, kusanganisira kupinza kwemurwere, kuyera kushanda kwemasikati muvarwere vane kushaya hope. Iyo yekurara domain mamakisi yeIDSIQ yakaongororwa seyakakosha yechipiri yekupedzisira mune zvese zvakakosha zvidzidzo uye kuenzanisa kune placebo kunosanganisira kutonga kwekuwanda. Daridorexant 50 mg yakaratidza kuvandudzwa kwakanyanya kwehuwandu mukurara kwemasikati pamwedzi mumwe chete nemwedzi 3. Domain yekurara nharaunda haina kunyanya kuvandudzwa pa 25 mg mune chero kudzidza pane imwe nguva. Daridorexant 50 mg zvakare yakavandudza iyo yakawedzera IDSIQ domain scores (alert/cognition domain, mood domain) uye yakazara mamaki (p-values ​​<0.0005 kupesana ne placebo isina kugadziridzwa kuwanda). Kuvandudzwa kwekushanda kwemasikati ne daridorexant 50 mg zvishoma nezvishoma yakawedzera pamusoro pemwedzi mitatu yekudzidza.

Zvose zviitiko zvezviitiko zvakashata zvakaenzaniswa pakati pemapoka ekurapa. Zviitiko zvakashata zvinoitika mune vanopfuura 5% yevatori vechikamu vaiva nasopharyngitis uye musoro. Pakanga pasina kuwedzera-kunoenderana nedosi muzviitiko zvakashata mukati meiyo dosing renji, kusanganisira somnolence uye kudonha. Kupfuurirazve, hapana kutsamira, rebound insomnia kana kuregera mhedzisiro zvakaonekwa pakuregeredza kurapwa. Pakati pemapoka ekurapa, zviitiko zvakashata zvinotungamira pakuregedzwa kwekurapa zvaive zvakanyanya kuwanda ne placebo pane daridoxant.

Martine Clozel, MD, uye Chief Scientific Officer weIdorsia, vakati:

"Idzi data rakaburitswa muThe Lancet Neurology rinoratidza kudzika kwehumbowo hwakagadzirwa muchirongwa chekuvandudza daridoexant uye zvimiro zvemushonga zvandinotenda zvinotsanangura mhedzisiro. Mushonga uyu wakagadzirwa kuti uve nehunyanzvi hwekurara kwekutanga uye kuchengetedza pazviyero zvinogoneka uku uchidzivirira kurara kwemangwanani kwasara. Iyi nhoroondo, pamwe chete nekuvhara kwakaenzana kwezvose zviri zviviri orexin receptors - izvo zvinogona kutungamira mukudzivirirwa kwechisingaperi tsitsi hyperactivity hunhu hwekusarara - inogona kutsanangura kuvandudzwa kwatinoona mukushanda kwemasikati ne50 mg ye daridoxant.

Daridexant mukushaya hope

Insomnia disorder inoratidzwa nekunetseka kutanga kana kuchengetedza kurara uye inosanganiswa nekutambudzika kana kukanganisa mukushanda kwemasikati. Kunyunyuta kwakasiyana-siyana kwemasikati, kubva kuneta uye kuderedzwa kwesimba kusvika kukuchinja mafungiro uye kuoma kwekuziva, kunonzi nevanhu vane kushaya hope.

Kusarara kunobatanidza nekunyanya kumuka system.

Daridorexant, novel dual orexin receptor antagonist, yakagadzirwa uye yakagadziridzwa neIdorsia yekurapa kushaya hope. Daridorexant inonangidzira kumuka kwakanyanya hunhu hwekusarara nekuvhara chiitiko che orexin. Daridorexant inonyanya kunanga iyo orexin system nemakwikwi kusunga neaviri mareceptor, nekudaro ichivharira nekudzoka basa reorexin.

Daridorexant ndeye FDA yakabvumidzwa muUS pasi pezita rekutengesa QUVIVIQ™ uye ichave iripo zvichitevera kurongwa neUS Drug Enforcement Administration muna Chivabvu 2022.

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Mupepeti mukuru we eTurboNew ndiLinda Hohnholz. Iye anogara muTN HQ muHonolulu, Hawaii.

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