Imvume ye-FDA yoNyango olutsha lwezigulana ezine-Alzheimer's Disease

I-Corium, i-Inc. ibhengeze namhlanje i-US Food and Drug Administration (FDA) ivume i-ADLARITY ye-Corium (i-donepezil transdermal system) njengonyango lwezigulane ezinobunzima obuncinci, obuphakathi, okanye obunzulu be-Alzheimer's type. I-ADLARITY yeyona patch yokuqala kunye neveki kuphela yokunikezela ngokuqhubekayo iidosi ezihambelanayo ze-donepezil ngolusu, okukhokelela kumathuba asezantsi eziphumo ebezingalindelekanga zesisu sesisu (GI) ezinxulumene ne-donepezil yomlomo. I-ADLARITY yimveliso yokuqala evunyiweyo yamayeza kagqirha esebenzisa ubuchwepheshe be-CORPLEX obunini be-CORPLEX, obusetyenziswe iminyaka kwiimveliso zabathengi.

I-Donepezil yolona nyango lumiselweyo kwiklasi ye-Alzheimer's inhibitors eyaziwa ngokuba yi-acetylcholinesterase inhibitors kwaye iyisithako esisebenzayo kwiyeza lomlomo i-Aricept®. I-donepezil yomlomo ifunxwa kwinkqubo yokugaya yesigulane, indlela ehambelana nemiphumo emibi ye-GI kunye nokuguquguquka koxinzelelo lweyeza elijikelezayo. I-ADLARITY ihambisa iintsuku ezisixhenxe zomthamo ofanayo we-donepezil eluswini lomguli, igcina inqanaba leyeza elifunekayo kunyango olusebenzayo. Ukuhanjiswa kwe-transdermal ye-donepezil ngokuthe ngqo kwesikhumba somgulane kudlula inkqubo yokugaya, okubangela ukuba kubekho imiphumo ephantsi ye-GI kunye nokwenza kube lula kwizigulane eziphila nesifo se-Alzheimer kunye nabanonopheli babo ukuba balawule unyango ngokuthembekileyo.

“Ubukho bephetshi elungiselelwe kanye ngeveki ye-donepezil inamandla okuba luncedo kakhulu kwizigulana, abanonopheli, kunye nababoneleli bezempilo. Inika idosi esebenzayo, enyamezeleke kakuhle kwaye izinzile kangangeentsuku ezisixhenxe kwizigulana ezingakwaziyo ukuthatha i-donepezil yomlomo yonke imihla ngokuthembekileyo ngenxa yenkumbulo engasebenzi kakuhle. Inokuthi ibonelele ngeenzuzo ezo zigulana eziye zanciphisa amandla okugwinya okanye zineempembelelo ze-GI ezinxulumene nokungeniswa kwe-donepezil yomlomo, "kusho uPierre N. Tariot, MD, umlawuli we-Banner Alzheimer's Institute ePhoenix, Ariz.

“Ndichulumancile kukuva ukuba kukho iyeza elitsha labantu abaphila ne-Alzheimer’s, elisebenzisa unyango olusele lukhona olunenguqulelo entsha. Esi siqwenga solusu kulula ukusisebenzisa sibonelela ngeebhonasi ezifuna ukulawulwa kanye ngeveki, nto leyo enciphisa uxanduva lwamaqabane anokhathalelo. Ngokuqinisekileyo eli linyathelo eliya phambili kwicala elichanekileyo, utshilo u-Lori La Bey, uMlingane woNkekelo kumama wakhe owayehlala enesifo sengqondo esiyingozi iminyaka engama-30, uMseki we-Alzheimer's Speaks, kunye noMseki weMephu yeDementia.

I-Corium inobuchwephesha obunzulu kwi-teknoloji ye-transdermal kunye nerekhodi elihamba phambili kwishishini lokuphuhlisa kunye nokuvelisa iimveliso ze-transdermal. Imvume ye-ADLARITY imele inyathelo elibalulekileyo kubunikazi be-Corium nobuchwephesha be-transdermal obuqinisekisiweyo be-CORPLEX. I-CORPLEX yaphuhliswa ngeenjongo zokuphucula uncedo lwezonyango kwizigulana ngokuzisa ngokuqhubekayo, ngokulawulwayo, nokukhululwa okuqhubekayo kwechiza ngexesha elichaziweyo. I-Corium iphuhlisa olunye unyango lwe-CNS isebenzisa ubuchwepheshe bayo be-CORPLEX kwaye igcina ipotfoliyo yelungelo elilodwa lomenzi wechiza egquma i-CORPLEX kunye ne-ADLARITY.

"Imvume ye-FDA ye-ADLARITY izisa ukuthengisa indlela entsha kunye neendlela ezintsha zokuhambisa ngokuqhubekayo uhlobo olunyamezelekileyo lwe-donepezil, iyeza elisetyenziswa kakhulu kwizigulane ezine-Alzheimer's disease," kusho uPerry J. Sternberg, uMongameli kunye ne-CEO yeCorium. "Ukuvunywa kwe-ADLARITY yomeleza ixabiso letekhnoloji ye-Corium entsha ye-CORPLEX, ubuchule bethu be-CNS, kunye nomsebenzi wethu wokuhambisa izisombululo eziguqula ukhathalelo kuluntu lwe-Alzheimer kunye nabanye abachatshazelwa zizifo ze-CNS. Siziva sinelungelo lokwenene lokuba nethuba lokunceda izigidi zabantu baseUnited States abaphila nesifo sika-Alzheimer, abo babathandayo, kunye nabo babanyamekelayo ngokhetho olutsha olunokujongana nemingeni ekhoyo ngoku kunyango nokunyamekela.”

I-FDA ivume ukusetyenziswa kwe-ADLARITY kanye ngeveki kwi-5 mg / ngosuku okanye i-10 mg / imihla ngemihla. Izigulane zingatshintshwa ukusuka kwi-5 mg / ngosuku okanye i-10 mg / imini yomlomo i-donepezil ngokuthe ngqo kwi-ADLARITY kanye ngeveki ngu-prescriber wabo. UKUDLA kubekwa lula sisigulana okanye umntu osinyamekelayo emqolo, ethangeni, okanye ezimpundu zesigulana.