A New Method for Treating Sleep Disorders

描述(申请人提供)：Biotek已经开发出一种透皮 褪黑素配方能够产生足够高的通量水平 小贴片提供与健康人相似的夜间褪黑素脉冲 年轻人。这样的分娩应该会使人昏昏欲睡、安稳睡眠和警觉 唤醒比现有的口服剂量形式更有效，也会更 很容易给受损或不合作的受试者服用。因为透皮贴剂 褪黑素提供自然水平的非侵入性人类激素释放， 它不应该导致耐受性或有害的副作用。经皮褪黑素 可能对夜班工作人员、缺乏健康生活能力的老年人有价值 内源性高幅度褪黑激素循环，长途航空旅行者，以及 那些有睡眠或季节性情绪障碍的人。在第一阶段，制作了GMP贴片 启动了稳定性研究，这是一项人类临床方案 是与马萨诸塞州波士顿的布里格姆和妇女？S睡眠中心共同开发的，以及一个 IND草案已经准备好了。第二阶段将进行一项人体临床研究，旨在 在良好控制的条件下建立安全性和测试有效性。 拟议的商业应用：褪黑素贴片应该促进其他循环荷尔蒙的经皮系统的发展，从而产生能够改变或恢复其他类型的荷尔蒙介导的行为的产品。

DESCRIPTION (provided by applicant): BIOTEK has developed a transdermal melatonin formulation capable of producing flux levels high enough to allow a small patch to deliver a night-time melatonin pulse similar to that of healthy young adults. Such delivery should foster drowsiness, restful sleep, and alert waking more effectively than available oral dose forms and would also be more easily administered to impaired or uncooperative subjects. Because transdermal melatonin provides non-invasive delivery of a human hormone at natural levels, it should not lead to tolerance or harmful side effects. Transdermal melatonin may be of value to night shift workers, elderly individuals who lack an endogenous high-amplitude melatonin cycle, long distance air travelers, and those with sleep or seasonal affect disorders. In Phase I GMP patches were made and characterized, stability studies were initiated, a human Clinical Protocol was developed with the Brigham and Women?s Sleep Center in Boston, MA, and a draft IND was prepared. Phase II will conduct a human clinical study aimed at establishing safety and testing efficacy under well-controlled conditions. PROPOSED COMMERCIAL APPLICATION: A melatonin patch should encourage development of transdermal systems for other cyclic hormones, leading to products capable of modifying or restoring other types of hormone-mediated behavior.