I-Corium, Inc. imemezele namuhla i-US Food and Drug Administration (FDA) igunyaze i-ADLARITY ye-Corium (uhlelo lwe-donepezil transdermal) njengendlela yokwelapha iziguli ezinokuwohloka komqondo okuncane, okulingene, noma okubi kakhulu kohlobo lwe-Alzheimer's. I-ADLARITY iyichibi lokuqala nesonto elilodwa kuphela eliqhubeka nokuletha imithamo engashintshi ye-donepezil esikhumbeni, okuholela emathubeni amancane okuba nemiphumela engemihle yesisu (i-GI) ehambisana ne-donepezil yomlomo. I-ADLARITY ingumkhiqizo wokuqala womuthi ogunyazwe kadokotela osebenzisa ubuchwepheshe be-Corium bobunikazi be-CORPLEX transdermal, obusetshenziswe iminyaka emikhiqizweni yabathengi.
I-Donepezil umuthi onqunyelwe kakhulu ekilasini lemithi ye-Alzheimer eyaziwa ngokuthi i-acetylcholinesterase inhibitors futhi iyisithako esisebenzayo emithini yomlomo i-Aricept®. I-donepezil yomlomo imuncwa ngohlelo lokugaya lwesiguli, umzila ohambisana nemiphumela engemihle ye-GI kanye nokushintshashintsha kokugcwala komuthi ojikelezayo. I-ADLARITY iletha izinsuku eziyisikhombisa zomthamo ongashintshi we-donepezil esikhumbeni sesiguli, okugcina izinga lomuthi elidingekayo ukuze zelashwe ngempumelelo. Ukulethwa kwe-transdermal kwe-donepezil ngqo esikhumbeni sesiguli kudlula uhlelo lokugaya ukudla, okuholela ekubeni nethuba eliphansi lemiphumela engemihle ye-GI nokwenza kube lula ngeziguli ezinesifo i-Alzheimer's kanye nabanakekeli bazo ukuphatha ukwelashwa ngokwethembeka.
“Ukutholakala kokwakhiwa kwepheshi kanye ngesonto le-donepezil kunamandla okuzuzisa kakhulu iziguli, abanakekeli kanye nabahlinzeki bezempilo. Inikeza umthamo osebenzayo, obekezelelwe kahle futhi ozinzile izinsuku eziyisikhombisa ezigulini ezingakwazi ukuthatha i-donepezil yomlomo nsuku zonke ngokuthembekile ngenxa yenkumbulo ekhubazekile. Ingase futhi inikeze izinzuzo kulezo ziguli eziye zancipha amandla okugwinya noma ezinemiphumela emibi ye-GI ehambisana nokungenwa kwe-donepezil yomlomo,” kusho u-Pierre N. Tariot, MD, umqondisi we-Banner Alzheimer's Institute e-Phoenix, Ariz.
“Kuyangijabulisa ukuzwa ukuthi kunomuthi omusha wabantu abanesifo i-Alzheimer’s, osebenzisa indlela yokwelapha ekhona ene-twist entsha. Lesi siqeshana sesikhumba esisebenziseka kalula sinikeza amabhonasi adinga ukulawulwa kanye ngesonto, okubuye kwehlise izibopho zozakwethu abanakekelayo. Lesi isinyathelo esibheke phambili ngempela endleleni efanele,” kusho u-Lori La Bey, u-Care Partner kunina owaphila nokuwohloka komqondo iminyaka engu-30, uMsunguli we-Alzheimer's Speaks, kanye noMsunguli We-Dementia Map.
I-Corium inobuchwepheshe obujulile kubuchwepheshe be-transdermal kanye nerekhodi elihamba phambili embonini lokuthuthukisa nokukhiqiza imikhiqizo ye-transdermal. Ukugunyazwa kuka-ADLARITY kumelela ingqopha-mlando ebalulekile yobunikazi be-Corium nobuchwepheshe obufakazelwe be-CORPLEX be-transdermal. I-CORPLEX yathuthukiswa ngenhloso yokuthuthukisa izinzuzo zomtholampilo ezigulini ngokuletha ukukhululwa okuqhubekayo, okulawulwayo, nokuqhubekayo komuthi ngesikhathi esinqunyiwe. I-Corium ithuthukisa ezinye izindlela zokwelapha ze-CNS isebenzisa ubuchwepheshe bayo be-CORPLEX futhi igcina iphothifoliyo eqinile yelungelo lobunikazi ehlanganisa i-CORPLEX ne-ADLARITY.
"Ukugunyazwa kwe-FDA kwe-ADLARITY kuletha ekumaketheni indlela entsha nentsha yokuletha ngokuqhubekayo uhlobo olubekezelelwa kahle lwe-donepezil, umuthi osetshenziswa kakhulu ezigulini ezinesifo i-Alzheimer," kusho uPerry J. Sternberg, uMongameli kanye ne-CEO ye-Corium. “Ukugunyazwa kwe-ADLARITY kuqinisa ukubaluleka kobuchwepheshe obusha be-CORPLEX be-Corium, ubuchwepheshe bethu be-CNS, kanye nomsebenzi wethu wokuletha izixazululo eziguqula ukunakekelwa komphakathi we-Alzheimer kanye nabanye abathintwe izifo ze-CNS. Sizizwa sinelungelo elikhulu lokuba nethuba lokusiza izigidi zabantu e-US abaphila nesifo i-Alzheimer's, abathandekayo babo, nabanakekeli babo ngendlela entsha engabhekana nezinselele zamanje zokwelashwa nokunakekelwa.”
I-FDA igunyaze ukusetshenziswa kanye ngeviki kwe-ADLARITY kumafomula angu-5 mg/ngosuku noma angu-10 mg/ngosuku. Iziguli zingashintshwa zisuke ku-5 mg/ngosuku noma ku-10 mg/ngosuku i-donepezil yomlomo ngokuqondile ziye ku-ADLARITY yangeviki ngayinye ngodokotela wazo. I-ADlarity ibekwa isiguli noma umnakekeli kalula emhlane, ethangeni, noma ezinqeni zesiguli.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The transdermal delivery of donepezil directly into a patient’s skin bypasses the digestive system, resulting in a low possibility of GI side effects and making it easier for patients living with Alzheimer’s disease and their caregivers to administer the treatment reliably.
- ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil.
- Donepezil is the most prescribed medication in a class of Alzheimer’s drugs known as acetylcholinesterase inhibitors and is the active ingredient in the oral medication Aricept®.
