TRANSDERMAL PROSTAGLANDIN E1 TO TREAT MALE IMPOTENCE

描述：（改编自申请人摘要）：拟定的研究目的 开发一种新的，可靠的和更用户可接受的方法来治疗男性 通过阴茎表面给予前列腺素E1治疗阳痿。 直到最近，最可靠的方法包括自我注射，这可能 引起针恐惧症并涉及组织损伤的风险。最近批准的 含药的尿道内前列腺素栓剂和口服形式的 西地法尼都提供了显着的好处，但栓剂涉及 使用侵入性尿道涂药器，而口服西地法尼昂贵， 系统地管理。申请人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输送。他 已经申请了第一阶段研究的支持五个具体目标是 建议1）使用人皮肤在体外制备和测试制剂， 透皮渗透试验，2）进行阴茎和阴道的研究 刺激兔子，和3）进行勃起研究的狗使用最 有前途的配方。第二阶段将着手开发一个方便的 申请方法，准备和提交IND，并进行FDA批准 安全性和生物利用度人体临床研究。 拟定商业应用：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