类中的第一个用于过敏反应的鼻内上腺素喷雾剂:剂量发现临床研究
Tair Lapidot1, Yuval Tal2, Dalia Megiddo1
1Nasus Pharma Ltd, Tel Aviv, Israel.
The journal of allergy and clinical immunology. Global
|June 11, 2025
概括
一种新的鼻上腺喷雾剂 (FMXIN002) 与传统的上腺自注射器相比,显示出更快,更高的吸收率. 这种无针装置为过敏反应治疗提供了稳定和安全的替代方案.
科学领域:
- 药理学 药理学是指药理学的学科.
- 过敏和免疫学 过敏和免疫学
- 药物输送系统 药物输送系统
背景情况:
- 过敏反应是一种严重的,危及生命的过敏反应,需要立即接受上腺素治疗.
- 目前的上腺素自注射器面临着可用性挑战,阻碍了及时的管理.
- FMXIN002介绍了一种新的,无针的鼻腔干粉上腺素配方作为替代治疗方法.
研究的目的:
- 为了评估FMXIN002 (3.6和4.0毫克) 的药理动力学,药理动力学和安全性,与标准肌内 (IM) 上腺素自注射器 (0.3毫克) 相比.
- 为了评估FMXIN002配方的稳定性.
主要方法:
- 一个开放的,单剂量,三疗法,交叉,随机的生物利用性研究.
- 涉及12名健康的成年参与者 (男性和女性).
- 包括在各种条件下测试FMXIN002的稳定性.
主要成果:
- FMXIN002 4.0mg与IM自注射器相比,在大多数受试者中显示出更快,更大的上腺素吸收.
- 91%的受试者在使用FMXIN002 4.0 mg时达到治疗性上腺素值,而在使用IM自注射器时为55%.
- FMXIN002 4.0毫克在服用后的最初几分钟内显示出显著更高的血上腺水平 (P = .0377).
- 在所有治疗方法中,药理动力学反应和安全性概况是可比的,副作用是轻微的,自我解决的.
- FMXIN002表现出高稳定性,包括在20 ± 5oC下5年.
结论:
- FMXIN002 4.0毫克鼻喷剂在过敏反应的关键治疗窗口内提供快速和增强的上腺素吸收.
- 这种无针,稳定和安全的设备为紧急过敏治疗提供了一个患者友好的替代方案.
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