Cocaine addiction medication EMB-001

可卡因成瘾药物 EMB-001

• 批准号: 8144929
• 负责人: Nicholas E. Goeders
• 金额: $ 95.16万
• 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8144929
• 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; public health relevance; research clinical testing; translational study

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: This proposal is focused on the development of EMB-001, a novel combination drug product for the treatment of cocaine addiction. The goal of the work is to advance EMB-001 through a Phase 1 clinical trial.

描述（由申请人提供）：长期目标：开发EMB-001用于治疗可卡因依赖。工作背景：可卡因依赖和滥用困扰着美国160万人，并给个人和整个社会带来巨大的成本。目前还没有批准用于治疗可卡因依赖的药物，迫切需要安全有效的治疗方法来治疗这种严重的疾病。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Embera NeuroTherapeutics正在开发EMB-001用于治疗可卡因成瘾。EMB-001是一种组合药物产品，包括两种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。这种新药的开发来自NIH资助的20年研究，研究压力和下丘脑-垂体-肾上腺（HPA）轴在成瘾中的作用。EMB-001已在多种可卡因成瘾动物模型和使用市售单一药物在可卡因依赖患者中进行的试点临床试验中证明有效。该提案旨在继续开发这种有前景的治疗药物，并将复方制剂推进临床试验。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提交所需的临床前药理学和毒理学研究。具体目标3：完成EMB-001的1期临床试验。在资助期结束时，我们将准备在可卡因依赖受试者的II期安全性和有效性研究中评估EMB-001。 公共卫生关系：该提案的重点是开发EMB-001，一种用于治疗可卡因成瘾的新型复方制剂。这项工作的目标是通过1期临床试验推进EMB-001。