Supernus Pharmaceuticals, Inc. yakazivisa kuti US Chikafu neDrug Administration (FDA) yakabvumidza yakawedzera chiratidzo cheQelbree (viloxazine yakawedzera-kuburitsa capsules) yekurapa yekutarisisa deficit hyperactivity disorder (ADHD) muvarwere vakuru vane makore gumi nemasere zvichikwira. Iyo FDA ikozvino yabvumidza Qelbree kurapwa kweAdHD muvana (kutangira pazera 18), vechidiki nevakuru.
Vanosvika mamiriyoni gumi nematanhatu evana, vechidiki, uye vakuru vane ADHD muUS Nepo vana vazhinji vane ADHD vachikura, vanosvika 16% yeavo vakaonekwa vaine ADHD muhuduku vanoramba vaine ADHD sevakuru.
"Kusvika nhasi, sarudzo dzisiri dzeADHD dzevakuru dzave shoma," akadaro Greg Mattingly, MD, mubatsiri wekutanga weSt. Charles Psychiatric Associates muSt. Louis, Mo. "Iyi mvumo inhau dzakanaka uye inopa sarudzo itsva mamirioni evakuru veAmerica vari kuedza kutsvaga kurapwa kwakakodzera kugadzirisa zviratidzo zvavo zveADHD. "
Qelbree ibhuku risingafungidziri rinotorwa kamwe-zuva nezuva kuti rionekwe zuva rose. Kubudirira uye kuvandudzwa kwechiratidzo kwakaonekwa pakutanga kwekurapa. Iyo ine yakaratidza kuchengetedzwa uye kushivirira mbiri, isina humbowo hwekushungurudzwa kunogona kuitika muzvidzidzo zvekiriniki. Mvumo yacho yakavakirwa pamhedzisiro yakanaka kubva kuongororo yakasarudzika, mapofu maviri, placebo-inodzorwa Phase III yeQelbree muvanhu vakuru vane ADHD uye inomiririra kubvumidzwa kwekutanga kweinovhero isingakurudzire kurapwa kwevakuru mumakore makumi maviri.
"Semutungamiri mumunda weCNS, takazvipira zvizere kunzwisisa zviri nani nzira yekurapa zvirwere zvakaoma seAdHD," akadaro Jack Khattar, Mutungamiriri uye CEO weSupernus Pharmaceuticals. “Mvumo yanhasi inoratidza kufambira mberi kukuru mukurapa ADHD uye chiitiko chinokosha pangosara gore rimwe chete pashure pokunge Qelbree abvumirwa kurapa varwere vevana. Isu tinodada kuunza sarudzo nyowani isingakurudzire vanhu vakuru mumusika mushure memakumi maviri emakore. "
Pamazuva ese anochinjika-dose pakati pe200mg kusvika 600mg, chirongwa chePhase III chakasangana nemagumo ekutanga anoratidza kudzikiswa kweshanduko kubva padanho rekutanga reAdult ADHD Investigator Symptom Rating Scale (AISRS) chibodzwa chose pakupera kwechidzidzo chaive chakakura zvakanyanya muvakuru. kurapwa neQelbree maringe ne placebo (p=0.0040). Kuvandudzika kwakakosha muAISRS subscale zvibodzwa zvekusateerera uye hyperactivity / impulsivity zviratidzo zvakaonekwawo muchidzidzo. Uyezve, chidzidzo chacho chakasangana nechinhu chinokosha chechipiri chekupedzisira chekupedzisira nehuwandu hwehuwandu (p = 0.0023) mukuchinja kubva kune imwe nheyo yeClinical Global Impression - Severity of Illness (CGI-S) Scale pavhiki 6. Mushonga unoshanda wakabvumirwa zvakanaka. Ndokumbira utarise Rumwe Ruzivo Rwakakosha Chekuchengetedza rwuri pazasi.
1 Qelbree yakadzidzwa mu 4 miedzo yekiriniki. Mune imwe ongororo yevana 6 kusvika kumakore 11 ezera, ADHD chiratidzo chekuderedzwa kwechiratidzo chaive chakakosha kune 100 mg uye 200 mg doses, kutanga pavhiki 1. Muchidzidzo chevechiri kuyaruka 12 kusvika kumakore 17 ezera, ADHD chiratidzo chekuderedza kuderedzwa kwaive nenhamba. zvakakosha ku400 mg, kutanga pavhiki 2. Muchidzidzo che-flexible-dose chevanhu vakuru 18 kusvika kumakore e65, kuderedzwa kwechiratidzo cheAdHD kwaive kwakakosha muvarwere veQelbree, kutanga pavhiki 2.
INOKOSHA INFORMATION INFORMATION
Qelbree inogona kuwedzera pfungwa dzekuzviuraya uye zviito, muvana nevakuru vane ADHD, kunyanya mukati memwedzi mishoma yekutanga yekurapwa kana kana dosi rachinjwa. Udza chiremba wako kana iwe uine (kana kana pane nhoroondo yemhuri ye) pfungwa dzekuzviuraya kana zviito usati watanga Qelbree. Tarisa mafungiro ako, maitiro, pfungwa, uye manzwiro panguva yekurapa naQelbree. Taura chero shanduko itsva kana kamwe kamwe muzviratidzo izvi pakarepo. Qelbree haifanirwe kutorwa nevarwere vanotorawo mimwe mishonga yekurwisa depression, kunyanya iya inonzi monoamine oxidase inhibitor kana MAOI, kana mimwe mishonga yeasthma.