Cocaine addiction medication EMB-001

可卡因成瘾药物 EMB-001

• 批准号: 8535265
• 负责人: Nicholas E. Goeders
• 金额: $ 84.56万
• 依托单位: LOUISIANA STATE UNIV HSC SHREVEPORT
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8535265
• 关键词: Acute; Animal Model; Area; Benzodiazepines; Clinic; Clinical Trials; Cocaine; Cocaine Abuse; Cocaine Dependence; Comorbidity; Contracts; Crime; Development; Dose; Drug Combinations; Drug Formulations; Drug Kinetics; Enrollment; Ensure; FDA approved; Funding; Goals; Grant; Health Sciences; Hydrocortisone; In Vitro; Individual; Investigational Drugs; Investigational New Drug Application; Laboratories; Lead; Legal patent; Licensing; Louisiana; Maintenance; Manufacturer Name; Medical; Metabolism; Metyrapone; Modeling; Oral; Oxazepam; Pathway interactions; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology and Toxicology; Phase; Phase I Clinical Trials; Pituitary-Adrenal System; Placebos; Principal Investigator; Rattus; Research; Research Personnel; Rodent; Role; Safety; Self Administration; Societies; Stress; Technology; Testing; Therapeutic; Toxicogenetics; Toxicology; United States National Institutes of Health; Universities; Withdrawal; Work; addiction; base; cost; defined contribution; dosage; experience; falls; healthy volunteer; human subject; inhibitor/antagonist; interest; novel; novel therapeutics; pre-clinical; research clinical testing; translational study

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.

长期目标：开发EMB-001用于治疗可卡因依赖。 背景：可卡因依赖和滥用困扰着美国160万人，并与巨大的 对个人和整个社会的成本。目前没有药物批准用于治疗 可卡因依赖性，并且迫切需要安全有效的治疗剂来治疗这种严重的病症。 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Embera NeuroTherapeutics 正在开发EMB-001用于治疗可卡因成瘾。EMB-001是组合药物产品，其包含 两种FDA批准的药物，苯二氮卓类药物奥沙西泮和皮质醇合成抑制剂甲吡酮。的 这种新药的开发来自于NIH资助的20年来对压力作用的研究， 下丘脑-垂体-肾上腺（HPA）轴在成瘾中的作用。EMB-001已被证明有效， 可卡因成瘾的多种动物模型和使用市售的 可卡因依赖患者的单药治疗。该提案旨在继续发展这一 有前景的治疗和推进组合药物产品进入临床测试。 具体目标如下：具体目标1：完成EMB-001的开发和制造。 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 成绩.具体目标3：完成EMB-001的1期临床试验。 在资助期结束后，我们将准备评估EMB-001在第2阶段的安全性和有效性 对可卡因依赖者的研究。