Kuvomerezeka kwa FDA kwa Chithandizo Chatsopano cha Odwala omwe Ali ndi Matenda a Alzheimer's

Corium, Inc. yalengeza lero US Food and Drug Administration (FDA) yavomereza Corium's ADLARITY (donepezil transdermal system) ngati chithandizo kwa odwala omwe ali ndi vuto la maganizo lochepa, lochepa, kapena lalikulu la mtundu wa Alzheimer's. ADLARITY ndiye chigamba choyamba komanso kamodzi pa sabata chopereka Mlingo wa donepezil mosalekeza pakhungu, zomwe zimapangitsa kuti pakhale mwayi wocheperako wokhudzana ndi matenda am'mimba (GI) okhudzana ndi oral donepezil. ADLARITY ndiye mankhwala oyamba ovomerezeka ovomerezeka pogwiritsa ntchito ukadaulo wa Corium's CORPLEX transdermal, womwe wakhala ukugwiritsidwa ntchito kwazaka zambiri pazinthu zogula.

Donepezil ndi mankhwala omwe amaperekedwa kwambiri m'gulu la mankhwala a Alzheimer's omwe amadziwika kuti acetylcholinesterase inhibitors ndipo ndizomwe zimagwiritsidwa ntchito pamankhwala apakamwa Aricept®. Oral donepezil imalowetsedwa kudzera m'matumbo a wodwala, njira yolumikizidwa ndi zotsatira za GI komanso kusinthasintha kwa kuchuluka kwa mankhwala omwe amafalitsidwa. ADLARITY amapereka masiku asanu ndi awiri a mlingo wokhazikika wa dopezil kudzera pakhungu la wodwala, kuti asunge mlingo wamankhwala wofunikira kuti athandizidwe bwino. The transdermal yobereka donepezil mwachindunji pakhungu la wodwala kulambalala dongosolo m'mimba, kuchititsa otsika kuthekera kwa GI mbali ndi kupangitsa kukhala kosavuta kwa odwala Alzheimer's matenda ndi owasamalira kupereka chithandizo modalirika.

"Kupezeka kwa chigamba kamodzi pa sabata cha donepezil kumatha kupindulitsa kwambiri odwala, osamalira, ndi othandizira azaumoyo. Amapereka mlingo wothandiza, wololera komanso wokhazikika kwa masiku asanu ndi awiri kwa odwala omwe sangathe kumwa dopezil tsiku lililonse chifukwa cha kukumbukira kukumbukira. Ikhozanso kupereka zopindulitsa kwa odwala omwe achepetsa mphamvu yakumeza kapena kukhala ndi zotsatira za GI zomwe zimagwirizanitsidwa ndi kuyamwa kwa oral donepezil, "anatero Pierre N. Tariot, MD, mkulu wa bungwe la Banner Alzheimer's Institute ku Phoenix, Ariz.

"Ndili wokondwa kumva kuti pali mankhwala atsopano a anthu omwe ali ndi matenda a Alzheimer's, omwe amagwiritsa ntchito mankhwala omwe alipo kale omwe ali ndi njira yatsopano yopotoka. Chigamba chosavuta kugwiritsa ntchito pakhunguchi chimapereka mabonasi omwe amangofunika kuperekedwa kamodzi pa sabata, zomwe zimachepetsanso udindo wa osamalira. Ichi ndi sitepe yopita patsogolo panjira yoyenera, "atero a Lori La Bey, Care Partner kwa amayi ake omwe adakhala ndi dementia kwa zaka 30, Woyambitsa Alzheimer's Speaks, ndi Co-founder wa Dementia Map.

Corium ali ndi ukadaulo wozama muukadaulo wa transdermal komanso mbiri yotsogola yamakampani yopanga ndi kupanga zinthu za transdermal. Chivomerezo cha ADLARITY chikuyimira gawo lofunika kwambiri paukadaulo wamakampani a Corium komanso wotsimikizika wa CORPLEX transdermal. CORPLEX idapangidwa ndi cholinga chokwaniritsa zabwino zachipatala kwa odwala popereka mankhwala mosalekeza, owongolera, komanso okhazikika pakanthawi yodziwika. Corium ikupanga zithandizo zina za CNS pogwiritsa ntchito ukadaulo wake wa CORPLEX ndipo ili ndi mbiri yolimba ya patent yophimba CORPLEX ndi ADLARITY.

"Chivomerezo cha FDA cha ADLARITY chimabweretsa kugulitsa njira yatsopano komanso yatsopano yoperekera nthawi zonse njira yolekerera ya donepezil, mankhwala omwe amagwiritsidwa ntchito kwambiri kwa odwala omwe ali ndi matenda a Alzheimer," anatero Perry J. Sternberg, Purezidenti ndi CEO wa Corium. "Kuvomerezedwa kwa ADLARITY kumalimbitsa ukadaulo wa Corium waukadaulo wa CORPLEX, ukadaulo wathu wa CNS, ndi cholinga chathu chopereka mayankho omwe amasintha chisamaliro cha anthu a Alzheimer's ndi ena omwe akhudzidwa ndi matenda a CNS. Tikuona kuti ndi mwayi waukulu kukhala ndi mwayi wothandiza anthu miyandamiyanda ku United States omwe ali ndi matenda a Alzheimer, okondedwa awo, ndi owasamalira ndi njira yatsopano imene ingathetsere mavuto amene akukumana nawo panopa pa nkhani ya chithandizo ndi chisamaliro.”

A FDA adavomereza kugwiritsa ntchito ADLARITY kamodzi pamlungu mu 5 mg/tsiku kapena 10 mg/tsiku. Odwala angasinthidwe kuchokera ku 5 mg / tsiku kapena 10 mg / tsiku pakamwa dopezil mwachindunji kwa kamodzi pamlungu kamodzi pamlungu ADLARITY ndi prescriber. KUCHITIKA mtima kumayikidwa ndi wodwala kapena womusamalira bwino pamsana, ntchafu, kapena matako.