TRANSDERMAL PROSTAGLANDIN E1 TO TREAT MALE IMPOTENCE

描述：(改编自申请人的摘要)：建议的研究目的 开发一种新的、可靠的、更容易被用户接受的治疗男性的方法 通过阴茎表面注射前列腺素E_1来治疗阳萎。 直到最近，最可靠的方法是自我注射，这可能会 引起针头恐惧症，并涉及组织损伤的风险。最近批准的 一种含药前列腺素尿道栓及其口服制剂 西地芬尼都提供了显著的好处，但栓剂涉及 在口服西地芬尼昂贵的情况下使用侵入性尿路敷贴器 系统地管理。申请者，Biotek的Nichols博士提供了 初步数据表明，勃起前列腺素E1可以 通过龟头或阴茎的外表面经皮传递的。他 已请求支持一项第一阶段研究。五个具体目标是 建议1)使用人体皮肤在体外制备和测试制剂 经皮渗透试验，2)阴茎和阴道的研究 对兔子的刺激，以及3)在狗身上进行勃起研究，使用最多的 前景看好的配方。然后，第二阶段将着手开发一种方便的 申请方法，准备和提交IND，并进行FDA批准的 安全性和生物利用度的人体临床研究。 建议的商业应用：不可用

DESCRIPTION: (adapted from the applicant's abstract): The proposed study aims to develop a new, reliable and more user-acceptable method for treating male impotence by administering prostaglandin E1 through the surface of the penis. Until recently, the most reliable methods involved self-injection, which may evoke needle phobia and involve risk of tissue damage. The recent approvals of a medicated intraurethral prostaglandin suppository and an oral form of sildefanil both offer significant benefits, but the suppository involves the use of an invasive urethral applicator while oral sildefanil is expensive and administered systemically. The applicant, Dr. Nichols, at BIOTEK has provided preliminary data to demonstrate that erectogenic prostaglandin E1 can be delivered transdermally through the external surface of the glans or penis. He has requested support for a Phase I study. Five specific aims have been proposed to 1) prepare and test formulations in vitro using human skin in transdermal permeation tests, 2) conduct studies of penile and vaginal irritation in rabbits, and 3) conduct erectile studies on dogs using the most promising formulation. Phase II will then proceed to develop a convenient method of application, prepare and submit and IND, and conduct a FDA-approved human clinical study of safety and bio-availability. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE