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Sethethefatsi se Secha sa Phekolo ea Bothata bo Boholo ba ho Tepella Maikutlo

ngotsoeng ke mohlophisi

Kajeno AbbVie e phatlalalitse hore e kentse kopo ea tlatsetso e ncha ea Lithethefatsi (sNDA) bakeng sa cariprazine (VRAYLAR®) ho US Food and Drug Administration (FDA) bakeng sa kalafo ea adjunctive ea lefu le leholo la khatello ea maikutlo (MDD) ho bakuli ba ntseng ba fumana kalafo e tsoelang pele ea antidepressant. . Tlhahiso e tšehetsoa ke liphetho tsa liteko tsa bongaka tse phatlalalitsoeng pele.

Thuto ea Phase 3 3111-301-001 e bontšitse phetoho e kholo ea kliniki le lipalo-palo ho tloha qalong ho ea ho beke ea botšelela ho Montgomery-Åsberg Depression Rating Scale (MADRS) palo eohle ea bakuli ba tšoaroang ka cariprazine ka 1.5 mg / letsatsi ha ba bapisoa le placebo. Phuputso ea bobeli e nolofaletsang ho ngolisa, RGH-MD-75, e bontšitse phetoho e kholo ea bongaka le lipalo-palo ho tloha qalong ho ea ho beke ea borobeli ho palo eohle ea MADRS bakeng sa bakuli ba tšoaroang ka cariprazine ka 2-4.5 mg / letsatsi ha ba bapisoa le placebo. Lithutong tsena ka bobeli, lintlha tsa ts'ireletso li ne li lumellana le boemo ba tšireletso bo thehiloeng ba cariprazine ho pholletsa le matšoao, ho se na liketsahalo tse ncha tsa tšireletso tse khethiloeng. Hape ho tšehetsa tlhahiso ke thuto ea RGH-MD-76 e ileng ea hlahloba polokeho ea nako e telele le mamello ea cariprazine libeke tse 26.

“Batho ba bangata ba nang le bothata bo boholo ba ho tepella maikutlo ba sokola ho fumana phekolo e fokotsang matšoao a bona a ho tepella maikutlo, ’me ba bangata ba nka lilemo ho fumana phekolo e nepahetseng. Cariprazine, ha e kenyelletsoa kalafo e tsoelang pele ea ho tepella maikutlo ho bakuli ba nang le bothata bo boholo ba ho tepella maikutlo, e bontšitse hore e ka fokotsa matšoao a tepeletseng maikutlo, "ho boletse Michael Severino, MD, motlatsi oa molula-setulo le mopresidente, AbbVie. "Re labalabela ho sebetsa haufi-ufi le FDA nakong ea tlhahlobo ea tlhahiso ea rona ho tlisa phekolo e ncha e ka bang teng ho bakuli ba nang le bothata bo boholo ba khatello ea maikutlo ba ntseng ba noa moriana o thibelang ho tepella maikutlo le ho batla thuso e eketsehileng. Tlhahiso ena e bonts'a boitlamo ba rona bo matla ba ho sebetsana le likheo tse eketsehileng tlhokomelong ea batho ba anngoeng ke mafu a kelello. ”

Cariprazine e rekisoa e le VRAYLAR® United States 'me e lumelloe ke FDA ho tšoara batho ba baholo ba nang le khatello ea maikutlo, ea manic a hlobaetsang le liketsahalo tse tsoakiloeng tse amanang le lefu la ho ferekana kelellong, hammoho le schizophrenia. Cariprazine e ntse e ntlafatsoa ke AbbVie le Gedeon Richter Plc. Bakuli ba fetang 8,000 lefatšeng ka bophara ba 'nile ba phekoloa ka cariprazine ho feta liteko tsa kliniki tsa 20 tse hlahlobang katleho le polokeho ea cariprazine bakeng sa mefuta e mengata ea mafu a kelello.

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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