Imvume ye-FDA yoNyango olutsha lwe-ADHD kubantu abadala

I-Supernus Pharmaceuticals, Inc. ibhengeze ukuba i-US Food and Drug Administration (i-FDA) ivume isalathisi esandisiweyo se-Qelbree (i-viloxazine i-capsules yokukhululwa okwandisiweyo) kunyango lwe-attention deficit hyperactivity disorder (ADHD) kwizigulane zabantu abadala abaneminyaka eyi-18 nangaphezulu. I-FDA ngoku ivume i-Qelbree yonyango lwe-ADHD ebantwaneni (ukususela kwiminyaka eyi-6), abafikisayo kunye nabantu abadala.

Malunga ne-16 yezigidi zabantwana, abafikisayo, kunye nabantu abadala abane-ADHD e-US Ngelixa abantwana abaninzi abane-ADHD beyikhulisile, ukuya kuthi ga kwi-90% yabo bafunyaniswa bene-ADHD ebuntwaneni bayaqhubeka nokuba ne-ADHD njengabantu abadala.

Ukuza kuthi ga namhlanje, ukhetho lwe-ADHD olungakhuthaziyo kubantu abadala luye lwancitshiswa kakhulu, utshilo uGreg Mattingly, MD, iqabane eliseka iSt. Charles Psychiatric Associates eSt. Louis, Mo. izigidi zabantu abadala baseMelika abazama ukufumana unyango oluchanekileyo ukulawula iimpawu zabo ze-ADHD. "

I-Qelbree yinoveli engakhuthaziyo ethathwa kanye yonke imihla ukuze ibonakale imini yonke. Ukusebenza kunye nokuphuculwa kweempawu kwabonwa kwangethuba kunyango. Ineprofayili eqinisekisiweyo yokhuseleko kunye nokunyamezela, kungekho bungqina bokusetyenziswa kakubi kwizifundo zeklinikhi. Ukuvunywa kusekelwe kwiziphumo ezihle ezivela kuphando olungenamkhethe, oluyimfama oluphindwe kabini, olulawulwa yi-placebo lweSigaba sesi-III se-Qelbree kubantu abadala abane-ADHD kwaye imele ukuvunywa kokuqala kwenoveli yonyango olungakhuthaziyo kubantu abadala kwiminyaka eyi-20.

"Njengenkokeli kwintsimi ye-CNS, sizinikezele ngokupheleleyo ekuqondeni ngcono indlela yokuphatha izifo ezinzima ezifana ne-ADHD," kusho uJack Khattar, uMongameli kunye ne-CEO ye-Supernus Pharmaceuticals. “Imvume yanamhlanje iphawula inkqubela ephambili kunyango lwe-ADHD yaye sisiganeko esibalulekileyo kunyaka nje omnye emva kokuvunywa kukaQelbree ukuba anyange abaguli. Siyazingca ngokuzisa inoveli entsha engabakhuthaziyo abantu abadala emarikeni emva kweminyaka engamashumi amabini. ”

Kwi-dose yemihla ngemihla eguquguqukayo phakathi kwe-200mg ukuya kwi-600mg, ulingo lweSigaba sesi-III ludibene nesiphelo sokuqala esibonisa ukuncitshiswa kotshintsho olusuka kwisiseko se-Adult ADHD Investigator Symptom Rating Scale (AISRS) inqaku lilonke ekupheleni kwesifundo lalilikhulu kakhulu ngokwezibalo kubantu abadala. iphathwe nge-Qelbree ngokuchasene ne-placebo (p=0.0040). Uphuculo olubonakalayo kumanqaku asezantsi e-AISRS okungakhathaleli kunye neempawu ze-hyperactivity / impulsivity nazo zabonwa kuphononongo. Ngaphezu koko, uphando ludibene neyona nto iphambili yokuphumelela kwesibini kunye nokubaluleka kwezibalo (p = 0.0023) ekutshintsheni ukusuka kwisiseko se-Clinical Global Impression - Ubunzima bokugula (CGI-S) Isikali kwiveki ye-6. Idosi esebenzayo yayinyamezeleke kakuhle. Nceda ubone ulwazi olongezelelweyo oluBalulekileyo loKhuseleko oluqukiwe apha ngezantsi.

I-1 Qelbree yafundwa kwizilingo zeklinikhi ze-4. Kuphononongo olunye lwabantwana abaneminyaka eyi-6 ukuya kwe-11 ubudala, ukuhla kweempawu ze-ADHD kwakubalulekile ngokwezibalo kwi-100 mg kunye ne-200 mg yedosi, ukuqala ngeveki 1. Kuphononongo lwabafikisayo kwi-12 ukuya kwi-17 yeminyaka ubudala, ukuhla kweempawu ze-ADHD kwakuncitshiswa ngokwezibalo. okubalulekileyo kwi-400 mg, ukuqala ngeveki ye-2. Kuphononongo lwedosi eguquguqukayo yabantu abadala be-18 ukuya kwi-65 yeminyaka ubudala, ukuncitshiswa kweempawu ze-ADHD kwakubaluleke kakhulu kwizigulane ze-Qelbree, ukuqala ngeveki ye-2.

IINKCUKACHA EZIBALULEKILEYO ZOKHUSELEKO

U-Qelbree unokwandisa iingcamango zokuzibulala kunye nezenzo, kubantwana nakubantu abadala abane-ADHD, ngakumbi kwiinyanga ezimbalwa zokuqala zonyango okanye xa umthamo utshintshile. Tshela ugqirha wakho ukuba unayo (okanye ukuba kukho imbali yentsapho) iingcamango zokuzibulala okanye izenzo ngaphambi kokuba uqale uQelbree. Beka iliso kwindlela oziva ngayo, indlela oziphethe ngayo, iingcinga, kunye neemvakalelo ngexesha lonyango noQelbree. Xela naluphi na utshintsho olutsha okanye olukhawulezileyo kwezi mpawu ngoko nangoko. I-Qelbree akufuneki ithathwe zizigulane ezikwathatha amayeza athile okudakumba, ngakumbi lawo abizwa ngokuba yi-monoamine oxidase inhibitor okanye i-MAOI, okanye amayeza athile e-asthma.