ADLARITY is FDA approved for patients with Alzheimer's DementiaData reinforce favorable skin tolerability and adhesion of first ever once-weekly transdermal system offering continuous delivery of Alzheimer's dementia drug donepezilBOSTON, Sept. 12, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, announced today the publication of data reinforcing that ADLARITY (donepezil transdermal system) demonstrated favorable skin tolerability and adhesion in a placebo-controlled trial with healthy volunteers.

ADLARITY已获得FDA批准，用于阿尔茨海默氏痴呆症患者，可增强有利的皮肤耐受性和首次每周一次的透皮系统粘附，提供持续递送阿尔茨海默氏痴呆药物donepezilBOSTON，2023年9月12日/PRNewswire/-Corium，LLC，一家领导新型神经科学疗法开发和商业化的商业阶段生物制药公司今天宣布发布数据，强化ADLARITY（多奈哌齐透皮系统）在与健康志愿者的安慰剂对照试验中表现出有利的皮肤耐受性和粘附性。

ADLARITY, developed by Corium, is the first and only U.S. FDA approved once-weekly, donepezil transdermal system for patients with mild, moderate and severe dementia of the Alzheimer's type. The data appear in the October-December 2023 issue of the peer-reviewed Alzheimer's Disease and Associated Disorders journal..

由Corium开发的ADLARITY是美国FDA批准的第一个也是唯一一个每周一次的多奈哌齐透皮系统，用于阿尔茨海默病轻度，中度和重度痴呆患者。这些数据出现在2023年10月至12月的同行评议的阿尔茨海默病和相关疾病杂志上。。

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ADLARITY continuously delivers consistent doses of donepezil through the skin, enabling a generally favorable overall gastrointestinal (GI) side effect profile. Donepezil, an acetylcholinesterase inhibitor and the active ingredient in the oral medication Aricept®, is the most prescribed Alzheimer's dementia medication in the United States. .

ADLARITY通过皮肤连续递送一致剂量的多奈哌齐，从而实现通常有利的整体胃肠（GI）副作用特征。多奈哌齐是一种乙酰胆碱酯酶抑制剂，口服药物Aricept®中的活性成分，是美国处方最多的阿尔茨海默氏痴呆药物。 .

ADLARITY (donepezil transdermal system) demonstrated favorable skin tolerability and adhesion in a placebo-controlled trial with healthy volunteers.

ADLARITY（多奈哌齐透皮系统）在健康志愿者的安慰剂对照试验中表现出有利的皮肤耐受性和粘附性。

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In the double-blind Phase 1 study (NCT03397862), 256 healthy adults received ADLARITY on one side of their back and a placebo patch on the other side. For three weeks, the investigators placed the patches once weekly on the same location—a condition in the study exaggerating real world use by placing the patches in the same place for three weeks successively.

在双盲1期研究（NCT03397862）中，256名健康成人在其背部的一侧接受了ADLARITY，在另一侧接受了安慰剂贴片。三周后，研究人员每周一次将贴片放置在同一位置-研究中的一种情况-通过将贴片连续三周放置在同一位置来夸大现实世界的使用。

In contrast, during routine patient use, ADLARITY's instructions for use advise patients not to place the patch in the same location for at least two weeks (14 days) after removal from that location. After three weeks, the tested ADLARITY patches caused none-to-minimal skin irritation in most subjects..

相反，在常规患者使用过程中，ADLARITY的使用说明建议患者在从该位置移除后至少两周（14天）不要将贴片放置在同一位置。三周后，测试的ADLARITY贴片在大多数受试者中没有引起最小的皮肤刺激。。

'These important data show that the once-weekly ADLARITY skin patch had good adhesion and overall mild to no skin irritation despite the exaggerated conditions used during testing,' said lead author Marwan N. Sabbagh, MD, Professor of Neurology. 'The results grow our understanding of ADLARITY's safety profile and provide additional information that should be helpful to clinicians when considering the only weekly skin patch formulation of donepezil for their Alzheimer's patients.''The skin irritation results showed a trend of better skin tolerability in study participants aged 65 or greater compared to those under 65, which is clinically relevant for the indicated patient population,' said Charles Oh, MD, Chief Medical Officer of Corium.

主要作者Marwan N.Sabbagh博士，神经病学教授说：“这些重要的数据显示，尽管在测试过程中使用了夸张的条件，但每周一次的皮肤贴片具有良好的粘附性，总体上轻微至无皮肤刺激性。”结果增加了我们对ADLARITY安全性概况的理解，并提供了额外的信息，这些信息应该对临床医生在考虑为阿尔茨海默病患者使用多奈哌齐的唯一每周皮肤贴剂配方时有所帮助Corium首席医疗官Charles Oh博士说，皮肤刺激结果显示，65岁或65岁以上的研究参与者与65岁以下的研究参与者相比，皮肤耐受性更好，这与指定的患者群体具有临床相关性。

'ADLARITY is an example of the value and commitment Corium brings to developing treatment options that address unmet needs of people with neurological conditions.'Study examines skin irritation, sensitization, and adherenceInvestigators measured any skin irritation at study days eight, 15 and 22 using a combined skin irritation score (CSIS) from the Dermal Response Scale and an Other Effects Scale, as recommended by the FDA.  After three weeks, the tested ADLARITY patches caused none-to-minimal skin irritation in most subjects, scoring an average 0.55 points (±0.78) of a possible maximum of 7 points using a calculation of the mean CSIS scores across the three weekly measures.

“ADLARITY是核心为开发治疗方案带来的价值和承诺的一个例子，这些方案可以解决神经系统疾病患者未满足的需求。”研究检查皮肤刺激，致敏和粘附性研究人员根据FDA的建议，使用皮肤反应量表和其他效应量表的综合皮肤刺激评分（CSIS）在研究第8,15和22天测量任何皮肤刺激。三周后，测试的ADLARITY补丁在大多数受试者中没有引起最小的皮肤刺激，使用三周测量中的平均CSIS评分计算平均0.55分（±0.78），可能最多7分。

The placebo patches scored 0.19 (±0.35), indicating no skin irritation. Of the 198 participants who completed the study, four had potential sensitization to ADLARITY, and none to the placebo patches.In general, on a weekly basis, the patches had good adhesion and essentially no lift from the skin. During the study 12 patches, seven of 735 ADLARITY and five of 736 pl.

安慰剂贴片得分为0.19（±0.35），表明没有皮肤刺激。在完成研究的198名参与者中，有4名对ADLARITY有潜在的敏感性，对安慰剂贴片没有任何敏感性。通常，每周，贴剂具有良好的粘附性并且基本上没有从皮肤上抬起。在研究期间，有12个补丁，735个ADLARITY中的7个和736 pl中的5个。

Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal..

应用部位皮肤反应：ADLARITY可能导致皮肤应用部位反应。这些反应不一定表示敏化；然而，过敏性接触性皮炎可能会发生，如果应用部位反应扩散到透皮系统的大小之外，则应该怀疑，有证据表明局部反应更强烈，并且在透皮系统去除后48小时内症状没有显着改善。。

Anesthesia: ADLARITY is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.

麻醉：麻醉期间，ADLARITY可能会夸大琥珀胆碱型肌肉松弛。

Cardiovascular conditions: ADLARITY may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil..

心血管疾病：ADLARITY可能对窦房结和房室结有迷走神经效应。这些影响可能表现为有或没有已知潜在心脏传导异常的患者的心动过缓或心脏传导阻滞。据报道晕厥发作与多奈哌齐的使用有关。。

Nausea and vomiting: ADLARITY may cause diarrhea, nausea, and vomiting. Although in most cases these effects have been transient, some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation and titration of ADLARITY.

恶心和呕吐：急性可能导致腹泻，恶心和呕吐。虽然在大多数情况下这些影响是短暂的，但有些情况持续1至3周。在开始和滴定ADLARITY期间应密切监测患者。

Peptic ulcer disease and gastrointestinal bleeding: ADLARITY may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)..

消化性溃疡病和胃肠道出血：ADLARITY可能会增加胃酸分泌。应密切监测患者的活动性或隐匿性胃肠道出血，特别是有溃疡病史或同时接受非甾体类抗炎药（NSAIDs）的患者。。

Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur.

泌尿生殖系统疾病：虽然在临床试验中未观察到，但可能发生膀胱流出道梗阻。

Seizures: ADLARITY is believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease.

癫痫发作：ADLARITY被认为有可能引起全身性惊厥；但是，癫痫发作活动也可能是阿尔茨海默氏病的表现。

Pulmonary conditions: ADLARITY should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

肺部疾病：对于有哮喘或阻塞性肺病病史的患者，应小心处理。

ADVERSE REACTIONSThe most common side effects of ADLARITY (>3%) were headache (15%), application site pruritus (9%), muscle spasms (9%), insomnia (7%), abdominal pain (6%), application site dermatitis (6%), constipation (6%), diarrhea (4%), application site pain (4%), dizziness (4%), abnormal dreams (4%) and skin laceration (4%).DRUG INTERACTIONSCholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications.

不良反应最常见的副作用（>3%）是头痛（15%），应用部位瘙痒（9%），肌肉痉挛（9%），失眠（7%），腹痛（6%），应用部位皮炎（6%），便秘（6%），腹泻（4%），应用部位疼痛（4%），头晕（4%），异常梦梦（4%）和皮肤撕裂（4%）。药物相互作用胆碱酯酶抑制剂，包括多奈哌齐在内，有可能干扰抗胆碱能药物的活性。

A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.For additional safety information, click here for the Prescribing Information and Patient Information.You are encouraged to report negative side effects of prescription drugs to the FDA.

当胆碱酯酶抑制剂与琥珀胆碱，类似的神经肌肉阻滞剂或胆碱能激动剂如氨甲酰胆碱同时给药时，可以预期协同作用。有关其他安全信息，请单击此处获取处方信息和患者信息。鼓励您向FDA报告处方药的不良副作用。

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.About CoriumCorium, LLC, is a biopharmaceutical company that is leading the development and commercialization of neuroscience therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S.

访问www.fda.gov/medwatch，或致电1-800-fda-1088。关于CoriumCorium，LLC，是一家生物制药公司，正在领导神经科学疗法的开发和商业化，为医生提供患者，家属的创新治疗方案，和他们的照顾者。Corium正在商业化两家美国。

FDA approved products, ADLARITY and AZSTARYS, in the U.S., and has licensed each for development and commercialization in certain territories outside the U.S. For further information, please visit http://www.corium.com.Contact: Corium, LLCGartman PR[email protected] 202-413-4226SOURCE Corium, LLC.

美国FDA批准的产品ADLARITY和AZSTARYS已获得美国以外某些地区的开发和商业化许可。有关详细信息，请访问http://www.corium.com.Contact:Corium，LLCGartman PR[电子邮件保护]202-413-4226来源Corium，LLC。