Cocaine addiction medication EMB-001

长期目标：开发用于治疗可卡因依赖的EMB-001。 背景：可卡因依赖和滥用困扰着美国160万人，并与巨大的 给个人和整个社会带来的代价。目前还没有被批准用于治疗糖尿病的药物 可卡因依赖，迫切需要安全有效的疗法来治疗这一严重疾病。 位于什里夫波特的路易斯安那州立大学健康科学中心(LSUHSC-S)和恩贝拉神经治疗学 正在开发用于治疗可卡因成瘾的EMB-001。EMB-001是一种联合用药产品，包括 FDA批准的两种药物，苯二氮卓类奥沙西潘和皮质醇合成抑制剂美曲拉酮。这个 这种新药的开发是由美国国立卫生研究院资助的20年来对压力和 成瘾中的下丘脑-垂体-肾上腺(HPA)轴。EMB-001已被证明是有效的 可卡因成瘾的多种动物模型和在使用商业上可获得的 可卡因依赖患者的单药使用情况。这项建议旨在继续发展这一 前景看好，并将联合用药产品推向临床试验。 具体目标如下：具体目标1：完成EMB-001的研制。 具体目标2：完成支持IND所需的临床前药理学和毒理学研究 呈件。具体目标3：完成EMB-001的一期临床试验。 在资助期结束时，我们将准备评估EMB-001第二阶段的安全性和有效性 对可卡因依赖受试者的研究。

Long Term Goal: To develop EMB-001 for the treatment of cocaine dependence. Background: Cocaine dependence and abuse afflict 1.6 million people in the U.S. and are associated with enormous costs to individuals and to the overall society. There are currently no medications approved for the treatment of cocaine dependence, and there is a compelling need for safe and effective therapeutics to treat this serious condition. The Louisiana State University Health Sciences Center in Shreveport (LSUHSC-S) and Embera NeuroTherapeutics are developing EMB-001 for the treatment of cocaine addiction. EMB-001 is a combination drug product comprising two FDA-approved medications, the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone. The development of this new medication emerged from 20 years of NIH-funded research into the role of stress and the hypothalamo-pituitary-adrenal (HPA) axis in addiction. EMB-001 has already been demonstrated to be effective in multiple animal models of cocaine addiction and in a pilot clinical trial carried out using the commercially available single agent drugs in cocaine-dependent patients. This proposal is aimed at continuing the development of this promising therapeutic and advancing the combination drug product into clinical testing. The Specific Aims are as follows: Specific Aim 1: To complete the development and manufacture of EMB-001. Specific Aim 2: To complete the preclinical pharmacology and toxicology studies needed to support an IND submission. Specific Aim 3: To complete a Phase 1 clinical trial of EMB-001. At the completion of the funding period, we will be prepared to evaluate EMB-001 in Phase 2 safety and efficacy studies in cocaine-dependent subjects.