Sehlahisoa sa pele se secha sa dexmethylphenidate bakeng sa Bana ba nang le ADHD

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Corium, Inc. e phatlalalitse hore poso ea eona, "Serdexmethylphenidate/d-Methylphenidate Capsules bakeng sa Bana ba nang le ADHD: Liphello ho SKAMP-C E hlahlobiloe ka Lihora tse 13 Thutong ea Phaposi ea Phaposi ea Phaposi ea Borutelo e laoloang ke Randomized, Double-blind, Placebo-controlled Laboratory," e tla hlahisoa. Academy of Managed Care Pharmacy (AMCP) ka la 30 Hlakubele 2022, Chicago, IL. Corium's oral capsule AZSTARYS (serdexmethylphenidate (SDX) le dexmethylphenidate (d-MPH)), e ntlafalitse haholo tlhokomelo le boitšoaro ka ho qala ha metsotso e 30 le ho fihlela lihora tse 13 ho bana ba lilemo tse 6 ho isa ho tse 12 ba fumanoeng ba na le tlhokomelo. deficit hyperactivity disorder (ADHD), ha e bapisoa le placebo. Mongoli o tla tlaleha liphuputso (poster # F21), ho tsoa tlhahlobong ea morao-rao ea boithuto ba bohlokoa ba Mokhahlelo oa 3, ho AMCP.

US Food and Drug Administration (FDA) e amohetse AZSTARYS e le kalafo ea hang ka letsatsi ea matšoao a ADHD ho bakuli ba lilemo tse 6 ho ea holimo ka la 2 Hlakubele 2021. AZSTARYS ke moriana oa pele ebile o le mong o nang le SDX, prodrug ea d-MPH, e fanang ka nako e telele ea ho lokolloa ha d-MPH letsatsi lohle. Hanngoe ka letsatsi AZSTARYS e fumaneha naha ka bophara US ho tse tharo tsa SDX/ho lokolloa hang-hang d-MPH matla a litekanyetso tsa 26.1/5.2 mg, 39.2/7.8 mg, le 52.3/10.4 mg.

"Tlhahlobo ena ea lintlha tse neng li bokelloa tekong ea bohlokoa e bonts'a hore ho qala ka potlako le nako e telele ea AZSTARYS ho fana ka ts'ebetso ea pele le e telele ea ho laola tlhokomelo le boitšoaro ho pholletsa le letsatsi la phekolo ea bakuli ba nang le ADHD. Liphetho tsena li fa bakuli, batsoali le litsebi tsa bophelo bo botle tlhahisoleseling ea bohlokoa eo ba ka e nahanang ha u khetha har'a liphekolo tse netefalitsoeng tsa ADHD. Re ananela monyetla oa ho arolelana lintlha tsena ho AMCP,” ho boletse Charles Oh, MD, Ofisiri e ka Sehloohong ea Bongaka ea Corium.

Liphuputso li tsoa tlhahlobisong ea barupeluoa thutong ea laboratori e laoloang ke placebo (NCT03292952), ho ipapisitsoe le lintlha tsa bona ho Swanson, Kotkin, Agler, M-Flynn, le Pelham (SKAMP) Rating Scale - Combined (SKAMP-C). ). SKAMP-C ke tekanyo e netefalitsoeng ea boitšoaro ba phaposi baneng ba nang le ADHD, ka lintlha tse tlase tse emelang ntlafatso le phokotso ea matšoao a ADHD. Bana, bao karolelano ea lilemo tsa bona e neng e le lilemo tse 9.6, ba ile ba nka SKAMP-C pele ba fuoa AZSTARYS kapa placebo, 'me makhetlo a robeli ka mor'a ho noa, ho qala ka metsotso e 30, ebe ka lihora tse 1, 2, 4, 8, 10, 12 le 13.

Tekanyo ea mantlha ea katleho tekong e ne e le ho fetoha ha karolelano ea lintlha tsa SKAMP-C ho tloha pele ho tekanyetso le ka makhetlo a mangata ka phaposing ea borutelo. Tlhahlobo ea post hoc e entsoe ho hokahanya lintlha le meralo e meng ea liteko tsa tleliniki tsa MPH, tse sebelisitseng hoseng ha letsatsi la phaposi ea borutelo, kapa ketelo ea boithuto e ts'oanang, e le motheo oa lintlha tsa pele tsa kalafo tsa SKAMP-C.

Karolelano ea liphetoho ho lintlha tsa SKAMP-C ho pholletsa le mehato eohle ea nako e ile ea ntlafatsoa haholo ka lintlha tsa -5.41 (p <0.001) bakeng sa barupeluoa ba fumanang AZSTARYS ha ba bapisoa le ba fumanang sebaka sa placebo, ka liphetoho tse fapaneng tsa lintlha tsa -4.87 vs. 0.54. Ka mokhoa o ts'oanang, lintlha tsa SKAMP-C tlhahlobong ea post hoc li bontšitse ntlafatso e kholo bakeng sa bana ba tšoaroang ka AZSTARYS ha ba bapisoa le sehlopha sa placebo. Tšimoloho ea phello ea phekolo e qalile ka metsotso ea 30 ka mor'a ho noa, ka phapang e khōlō ea lintlha tsa -3.97 pakeng tsa lihlopha (P <0.001), 'me e tsoela pele ka lihora tsa 13 ka mor'a ho noa, ka phapang e khōlō ea lintlha tsa -3.49 (P = 0.004).

Bafuputsi ba tlalehile hore ha ho na liketsahalo tse mpe tse tebileng (AEs) thutong. Li-AE tse tlalehiloeng li ne li tloaelehile kalafo ea methylphenidate, 'me bongata bo ne bo lekantsoe e le bonolo ho isa boemong bo itekanetseng ka ho teba. Li-AE tseo tse hlahang hangata ho sehlopha sa ASZTARYS (ka karolo ea 2 lekholong kapa ho feta ho barupeluoa) ha li bapisoa le sehlopha sa placebo e ne e le hlooho (5.4 vs. 1.3 lekholong, AZSTARYS le placebo ka ho latellana), bohloko bo ka holimo ba mpa (4.1 vs. 1.3 lekholong), ho hlobaela (2.7 vs. 1.3 lekholong), le pharyngitis ('metso o bohloko) (2.7 vs. 0 lekholong).

Nyeoe e ngolisitse bana ba 155 ba lilemo tse 6 ho isa ho tse 12 nakong ea libeke tse tharo, mohato oa ho ntlafatsa lethal dose le bulehileng. Har'a bana bao, ba 150 ba ne ba e-na le nako ea phekolo ea matsatsi a supileng, e sa boneng habeli, e laoloang ke placebo.

Mabapi le mongoli

Avatar ea Linda Hohnholz

Linda Hohnholz

Mohlophisi e ka sehloohong bakeng sa eTurboNews e thehiloe ho eTN HQ.

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