FDA批准多奈哌齐透皮贴剂获批用于治疗阿尔茨海默症

2022-03-19 网络 网络

FDA Approved: Yes (First approved March 11, 2022)

FDA Approved: Yes (First approved March 11, 2022)
Brand name: Adlarity
Generic name: donepezil
Dosage form: Transdermal System
Company: Corium, Inc.
Treatment for: Alzheimer's Disease

2022 年 03 月 14 日,美国波士顿一家名为Corium, Inc的公司宣布FDA已批准其研发的Adlarity(donepezil transdermal system,多奈哌齐透皮贴片)用于治疗患有轻度、中度或重度阿尔茨海默症患者。该公司是一家领先的新型中枢神经系统 (CNS) 疗法开发和商业化的商业阶段生物制药公司,Corium来自拉丁语,为皮革之意。在2020年1月NDA,见:FDA已接受ADLARITY(多奈哌齐透皮系统)的NDA以治疗阿尔茨海默病

多奈哌齐透皮贴剂

多奈哌齐透皮贴剂(Adlarity)是一种每周给药一次的包含活性成分多奈哌齐的温和贴剂,可以连续贴敷7天,维持稳定剂量的药物,并具有稳定的粘附性。这种给药方式可以避免存在记忆缺陷的患者每日给药带来的不便。该贴剂能稳定缓慢多奈哌齐,而透皮系统能定期通过皮肤递送药物,减少胃肠道吸收相关的不良反应。该透皮贴剂目前有两种规格:5mg和10mg。

多奈哌齐(Donepezil)作为目前阿尔茨海默病药物处方中使用最多的药物,是口服药物 Aricept® 的活性成分。多奈哌齐是六氢吡啶类氧化物,是第二代可逆转中枢乙酰胆碱抑制剂。口服多奈哌齐直接作用于消化道,药物吸收的不稳定会造成循环系统中药物浓度的波动。而透皮贴剂则是避免口服频繁给药,药物经皮递送,长时间维持稳定的血药浓度,并且不经消化道吸收避免了相关副作用的产生。

关键要点:

  • 阿尔茨海默病是一种进行性和不可逆的脑部疾病,涉及脑组织的变化,包括蛋白质的异常积累和神经元功能的丧失。它的特点是记忆、推理和思维能力的丧失。多奈哌齐通过抑制乙酰胆碱酯酶来促进大脑中神经递质乙酰胆碱的浓度。
  • 多奈哌齐于 1996 年首次被批准为口服片剂制剂,商标名为 Aricept,用于治疗阿尔茨海默病型痴呆。口服多奈哌齐与胃肠道副作用和药物血浆浓度波动有关。
  • Adlarity 旨在通过患者皮肤提供 7 天一致剂量的多奈哌齐,绕过消化系统以减少胃肠道副作用的可能性。
  • Adlarity 透皮系统每周一次应用于皮肤。
  • Adlarity 可能导致严重的不良反应,包括应用部位皮肤反应、心动过缓、恶心和呕吐、消化性溃疡病和胃肠道出血、膀胱流出道阻塞、癫痫发作和肺部疾病。 常见的副作用包括头痛、应用部位瘙痒、肌肉痉挛、失眠、腹痛、应用部位皮炎、便秘、腹泻、应用部位疼痛、头晕、梦境异常和皮肤撕裂。

CorplexTM技术平台

Corium的CorplexTM技术平台是一个专门开发透皮制剂的平台,该平台使经皮疗法获得了重大发展,包括经皮递送此前被认为无法递送的小分子药物。Adlarity是Corium公司首款使用该透皮技术的获批处方药,该技术已在很多产品开发中成功应用,包括液体(喷雾剂)、半固体(凝胶、软膏)、固体(颗粒、粉末、贴剂)。
该技术平台的具体特点:
1)可控并持续有效递送药物;
2)可长时间稳定黏附在潮湿或者干燥表面;
3)无刺激性,不会引发过敏;
4)可在皮肤上灵活移动。
5)使用方面,并且易于去除。
参考文献:https://www.corium.com/

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    2022-03-23 bugit
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    2023-01-24 cenghis
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    2022-03-21 杨海东

    坚持学习

    0

  8. 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