Supernus Pharmaceuticals, Inc. e phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) e amohetse pontšo e atolositsoeng bakeng sa Qelbree (viloxazine li-capsules tse lokollotsoeng ka nako e telele) bakeng sa phekolo ea bothata ba ho se tsotelle (ADHD) ho bakuli ba baholo ba lilemo li 18 le ho feta. FDA e se e amohetse Qelbree bakeng sa kalafo ea ADHD ho bana (ho qala ka lilemo tse 6), bacha le batho ba baholo.
Hoo e ka bang bana ba limilione tse 16, bacha le batho ba baholo ba na le ADHD United States Le hoja bana ba bangata ba nang le ADHD ba e-na le eona, ho fihlela ho 90% ea ba fumanoang ba e-na le ADHD bongoaneng ba tsoela pele ho ba le ADHD ha ba se ba le batho ba baholo.
"Ho fihlela kajeno, likhetho tsa ADHD tse sa thabiseng bakeng sa batho ba baholo li fokotsehile haholo," ho boletse Greg Mattingly, MD, molekane ea thehileng St. Charles Psychiatric Associates St. Louis, Mo. "Tumelo ena ke litaba tse monate 'me e fana ka khetho e ncha bakeng sa limillione tsa batho ba baholo ba Amerika ba lekang ho fumana phekolo e nepahetseng ho laola matšoao a bona a ADHD.”
Qelbree ke buka e sa khothaletseng ho nkuoa hang ka letsatsi bakeng sa ho pepeseha letsatsi lohle. Katleho le ntlafatso ea matšoao li ile tsa bonoa qalong ea kalafo. E na le boemo bo netefalitsoeng ba polokeho le mamello, ha ho na bopaki ba monyetla oa tlhekefetso lithutong tsa bongaka. Tumello e ipapisitse le liphetho tse ntle tse tsoang boithutong bo sa reroang, bo sa boneng habeli, bo laoloang ke placebo ea Phase III ea Qelbree ho batho ba baholo ba nang le ADHD mme e emela tumello ea pele ea kalafo e sa hlakiseng batho ba baholo lilemong tse 20.
"Joaloka moetapele lefapheng la CNS, re ikemiselitse ka botlalo ho utloisisa hamolemo mokhoa oa ho phekola mafu a rarahaneng a kang ADHD," ho boletse Jack Khattar, Mopresidente le CEO oa Supernus Pharmaceuticals. “Kamohelo ea kajeno e tšoaea tsoelo-pele e khōlō phekolong ea ADHD ’me ke mohato oa bohlokoahali selemo se le seng feela ka mor’a tumello ea Qelbree ea ho phekola bakuli ba bana. Re motlotlo ho tlisa khetho e ncha e sa thabiseng bakeng sa batho ba baholo 'marakeng ka mor'a lilemo tse mashome a mabeli. "
Ka tekanyo e feto-fetohang ea letsatsi le letsatsi pakeng tsa 200mg ho 600mg, teko ea Phase III e ile ea kopana le ntlha ea mantlha e bontšang phokotso ea phetoho ho tloha motheong oa Adult ADHD Investigator Symptom Rating Scale (AISRS) kakaretso ea lintlha qetellong ea thuto e ne e le kholoanyane haholo ho batho ba baholo. kalafo ka Qelbree khahlano le placebo (p=0.0040). Ntlafatso e kholo ea matšoao a ho se tsotelle a AISRS le matšoao a ts'oaetso / a ts'usumetso e boetse e bonoa thutong. Ho feta moo, thuto e ile ea kopana le ntlha ea bohlokoa ea katleho ea bobeli e nang le bohlokoa ba lipalo-palo (p = 0.0023) phetohong ho tloha motheong oa Clinical Global Impression - Severity of Illness (CGI-S) Scale bekeng ea 6. Tekanyo e sebetsang e ne e mamelloa hantle. Ka kopo, bona Lintlha tse ling tsa Bohlokoa tsa Tšireletseho tse kenyellelitsoeng ka tlase.
1 Qelbree e ile ea ithutoa litekong tse 4 tsa bongaka. Phuputsong e 'ngoe ea bana ba 6 ho ea ho lilemo tse 11, ho fokotseha ha matšoao a ADHD ho ne ho le bohlokoa ka lipalo bakeng sa litekanyetso tsa 100 mg le 200 mg, ho qala ka beke ea 1. Thutong ea bacha ba 12 ho ea ho lilemo tse 17, phokotso ea matšoao a ADHD e ne e le lipalo-palo. bohlokoa bakeng sa 400 mg, ho qala ka beke ea 2. Thutong ea tekanyo e feto-fetohang ea batho ba baholo ba 18 ho ea ho lilemo tse 65, ho fokotseha ha matšoao a ADHD ho ne ho le bohlokoa haholo ho bakuli ba Qelbree, ho qala ka beke ea 2.
TLHOKOMELISO LITLHAKISO TSA BOTSOALLE
Qelbree e ka eketsa mehopolo le liketso tsa ho ipolaea, ho bana le batho ba baholo ba nang le ADHD, haholo-holo nakong ea likhoeli tse seng kae tsa pele tsa phekolo kapa ha lethal dose le fetoloa. Bolella ngaka ea hau haeba u na le (kapa haeba ho na le pale ea lelapa ea) mehopolo kapa liketso tsa ho ipolaea pele u qala Qelbree. Lekola maikutlo a hau, boitšoaro, mehopolo le maikutlo nakong ea kalafo le Qelbree. Tlaleha liphetoho leha e le life tse ncha kapa tsa tšohanyetso matšoao ana hang-hang. Qelbree ha ea lokela ho nooa ke bakuli bao le bona ba noang meriana e itseng e thibelang ho tepella maikutlo, haholo-holo e bitsoang monoamine oxidase inhibitor kapa MAOI, kapa meriana e itseng ea asthma.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- At a daily flexible-dose between 200mg to 600mg, the Phase III trial met the primary endpoint showing the reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo (p=0.
- The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
- “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.
