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IAvatar kaLinda Hohnholz
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U-AbbVie namhlanje ubhengeze ukuba ungenise iSicelo esitsha seDrugs (sNDA) se-cariprazine (VRAYLAR®) kwi-US Food and Drug Administration (FDA) yonyango olongezelelweyo lwe-depressive disorder (MDD) kwizigulane ezifumana unyango oluqhubekayo lwe-antidepressant. . Ukungeniswa kuxhaswa ziziphumo ezivela kwizilingo zeklinikhi ezichazwe ngaphambili.

ISigaba sesi-3 soFundo lwe-3111-301-001 lubonise utshintsho olubalulekileyo lwekliniki kunye nezibalo ukusuka kwisiseko ukuya kwiveki yesithandathu kwi-Montgomery-Åsberg i-Depression Rating Scale (MADRS) amanqaku apheleleyo kwizigulane eziphathwe nge-cariprazine kwi-1.5 mg / ngosuku xa kuthelekiswa ne-placebo. Uphononongo lwesibini oluvumela ukubhaliswa, i-RGH-MD-75, lubonise utshintsho lweklinikhi kunye nezibalo ukusuka kwisiseko ukuya kwiveki yesibhozo kwi-MADRS amanqaku apheleleyo kwizigulane eziphathwe nge-cariprazine kwi-2-4.5 mg / ngosuku xa kuthelekiswa ne-placebo. Kuzo zombini ezi zifundo, idatha yokhuseleko yayihambelana neprofayili yokhuseleko olusekiweyo lwe-cariprazine kuzo zonke izibonakaliso, kungekho ziganeko ezintsha zokhuseleko ezichongiweyo. Kwakhona ukuxhasa ukungeniswa kukufunda i-RGH-MD-76 evavanye ukhuseleko lwexesha elide kunye nokunyamezela kwe-cariprazine kwiiveki ze-26.

“Abantu abaninzi abanengxaki yoxinzelelo olukhulu bayasokola ukufumana unyango olunciphisa iimpawu zabo zokudakumba, uninzi lwabo luthatha iminyaka ukufumana unyango olululo. I-Cariprazine, xa ifakwe kwi-anti-depressant eqhubekayo yonyango kwizigulane ezinoxinzelelo olukhulu, ibonise ukuba inokunciphisa iimpawu ezixinzelelekileyo, "kusho uMichael Severino, MD, u-vice-sihlalo kunye nomongameli, u-AbbVie. "Sijonge phambili ekusebenzeni ngokusondeleyo ne-FDA ngexesha lokuphononongwa kokungeniswa kwethu ukuzisa unyango olutsha olunokubakho kwizigulana ezinoxinzelelo olukhulu oluthatha i-antidepressant kwaye zifuna uncedo olongezelelweyo. Oku kuthunyelwe kubonisa ukuzibophelela kwethu ngamandla ekujonganeni nezikhewu ezongezelelweyo kukhathalelo lwabantu abachatshazelwe zizigulo zengqondo. ”

I-Cariprazine ithengiswa njenge- VRAYLAR® e-United States kwaye i-FDA-ivunyiwe ukuba iphathe abantu abadala ngokudakumba, i-manic acute kunye ne-mixed episodes ezinxulumene ne-bipolar I disorder, kunye ne-schizophrenia. I-Cariprazine iphuhliswa ngokubambisana ngu-AbbVie kunye no-Gedeon Richter Plc. Ngaphezulu kwezigulane ze-8,000 emhlabeni jikelele ziye zaphathwa nge-cariprazine ngaphezu kwezilingo zeklinikhi ze-20 ezivavanya ukusebenza kunye nokhuseleko lwe-cariprazine kuluhlu olubanzi lweengxaki zengqondo.

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IAvatar kaLinda Hohnholz

Linda Hohnholz

Umhleli oyintloko we eTurboNews esekwe kwi-eTN HQ.

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