Amincewar FDA don Sabon Magani na Marasa lafiya tare da Cutar Alzheimer

A KYAUTA Kyauta 5 | eTurboNews | eTN
Written by Linda Hohnholz

Corium, Inc. ya sanar a yau Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da Corium's ADLARITY (donepezil transdermal system) azaman jiyya ga marasa lafiya masu rauni, matsakaita, ko matsananciyar lalata irin ta Alzheimer. ADLARITY shine facin farko kuma sau ɗaya kawai na mako-mako don ci gaba da isar da daidaitattun allurai na donepezil ta cikin fata, wanda ke haifar da ƙarancin yuwuwar illolin cutar gastrointestinal (GI) masu alaƙa da baki donepezil. ADLARITY shine samfurin magani na farko da aka amince da shi ta hanyar amfani da fasahar fasahar transdermal ta Corium ta CORPLEX, wacce aka yi amfani da ita tsawon shekaru a cikin samfuran mabukaci.

Donepezil shine magani mafi wajabta a cikin nau'in magungunan Alzheimer wanda aka sani da acetylcholinesterase inhibitors kuma shine sashi mai aiki a cikin maganin baka na Aricept®. Donedpezil na baka yana tsotsewa ta hanyar tsarin narkewar majiyyaci, hanyar da ke da alaƙa da illolin GI da hauhawar yawan adadin ƙwayoyi a wurare dabam dabam. ADLARITY tana ba da kwanaki bakwai na daidaitaccen kashi na donepezil ta fatar majiyyaci, yana kiyaye matakin maganin da ake buƙata don ingantaccen magani. Isar da transdermal na donepezil kai tsaye a cikin fata na majiyyaci yana ƙetare tsarin narkewar abinci, yana haifar da ƙarancin yuwuwar illolin GI da sauƙaƙa wa marasa lafiya da ke zaune tare da cutar Alzheimer da masu kula da su don gudanar da jiyya cikin dogaro.

“Samun tsarin facin sati-sati na donepezil yana da yuwuwar amfana sosai ga marasa lafiya, masu ba da kulawa, da masu ba da lafiya. Yana ba da tasiri, jurewa da kwanciyar hankali na tsawon kwanaki bakwai ga marasa lafiya waɗanda ba za su iya ɗaukar donepezil na baka yau da kullun ba saboda ƙarancin ƙwaƙwalwa. Hakanan zai iya ba da fa'idodi ga waɗancan marasa lafiya waɗanda suka rage ikon haɗiye ko kuma suna da tasirin sakamako na GI waɗanda ke da alaƙa da cin abinci na bakin donepezil, ”in ji Pierre N. Tariot, MD, darektan Cibiyar Banner Alzheimer ta Cibiyar a Phoenix, Ariz.

"Na yi farin ciki da jin akwai wani sabon magani ga mutanen da ke fama da cutar Alzheimer, wanda ke amfani da maganin da ake amfani da shi tare da sabon salo. Wannan facin fata mai sauƙin amfani yana ba da kari na buƙatun gudanar da shi sau ɗaya-mako-mako, wanda hakan kuma yana rage nauyin abokan hulɗar kulawa ma. Wannan ko shakka babu wani mataki ne na ci gaba a kan hanyar da ta dace, "in ji Lori La Bey, Abokin Kula da Mahaifiyarta wadda ta rayu tare da cutar hauka tsawon shekaru 30, Wanda ya kafa Alzheimer's Speaks, kuma Co-founder na Dementia Map.

Corium yana da ƙwarewa mai zurfi a cikin fasahar transdermal da kuma tsarin jagorancin masana'antu na haɓakawa da kera samfuran transdermal. Amincewar ADLARITY tana wakiltar muhimmin ci gaba ga mallakar mallakar Corium da ingantacciyar fasahar transdermal ta CORPLEX. An haɓaka CORPLEX tare da manufar haɓaka fa'idodin asibiti ga marasa lafiya ta hanyar isar da ci gaba, sarrafawa, da ci gaba da sakin magani akan ƙayyadadden lokaci. Corium yana haɓaka wasu hanyoyin kwantar da hankali na CNS suna amfani da fasahar ta CORPLEX kuma tana kiyaye ƙaƙƙarfan fayil ɗin haƙƙin mallaka wanda ke rufe CORPLEX da ADLARITY.

"Amincin FDA na ADLARITY yana kawo wa kasuwa sabuwar hanya mai ban sha'awa don isar da daidaitaccen nau'i na donpezil mai jurewa, maganin da aka fi amfani dashi ga marasa lafiya da cutar Alzheimer," in ji Perry J. Sternberg, Shugaba da Shugaba na Corium. “Yin amincewar ADLARITY yana ƙarfafa ƙimar sabuwar fasahar CORPLEX ta Corium, ƙwarewar CNS, da manufarmu don isar da mafita waɗanda ke canza kulawa ga al'ummar Alzheimer da sauran waɗanda cututtukan CNS suka shafa. Muna jin daɗin gaske don samun damar da za mu iya taimaka wa miliyoyin mutane a Amurka da ke fama da cutar Alzheimer, ƙaunatattunsu, da masu kula da su tare da sabon zaɓi wanda zai iya magance wasu ƙalubalen yanzu na jiyya da kulawa. "

FDA ta amince da amfani da ADLARITY sau ɗaya kowane mako a cikin 5 MG / rana ko 10 mg / rana. Ana iya canza marasa lafiya daga 5 MG/rana ko 10 mg/rana na baka donedpezil kai tsaye zuwa ADLARITY na mako-mako sau ɗaya ta mai rubuta su. ADLARITY yana dacewa da majiyyaci ko mai kulawa akan bayan majiyyaci, cinya, ko gindi.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

  • 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®.

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Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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