Development of Alkontrol herbal for Treating Alcohol Abuse

开发用于治疗酒精滥用的 Alkontrol 草药

• 批准号: 9504564
• 负责人: SCOTT E LUKAS
• 金额: $ 50万
• 依托单位: NATURAL PHARMACIA INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-20 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9504564
• 关键词: Accidents; Acute; Adverse effects; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcoholic beverage heavy drinker; Alcoholism; Alcohols; Attention; Award; Back; Biological Assay; Biological Availability; Biological Markers; Biotechnology; Botanicals; Businesses; Cessation of life; China; Clinical Research; Clinical Trials; Collaborations; Development; Dose; Drug Kinetics; FDA approved; Fetal Alcohol Syndrome; Heavy Drinking; High Pressure Liquid Chromatography; Homicide; Hospitals; Human Volunteers; Individual; Injury; Institutional Review Boards; International; Isoflavones; Kudzu; Label; Laboratories; Laboratory Study; Legal patent; Measures; Methods; Modeling; Monitor; Morbidity - disease rate; Motor; Names; National Institute on Alcohol Abuse and Alcoholism; Outpatients; Pattern; Performance; Persons; Pharmaceutical Preparations; Phase; Plants; Plasma; Population; Positioning Attribute; Precipitation; Preparation; Primary Health Care; Procedures; Process; Production; Property; Protocols documentation; Public Health; Publishing; Pueraria lobata; Quality Control; Ramp; Reporting; Research Infrastructure; Safety; Sleep Wake Cycle; Small Business Technology Transfer Research; Source; Standardization; Testing; Time; Vertebral column; Work; alcohol abuse therapy; alcohol seeking behavior; alcohol use disorder; analytical method; assault; binge drinker; binge drinking; college; commercialization; daidzin; drinking; efficacy study; human subject; medical schools; medication compliance; product development; puerarin; safety study; scale up; sexual assault; treatment duration; urinary

This application for a Fast Track STTR award represents a collaboration between Natural Pharmacia International, Inc. (NPI) and McLean Hospital to initiate steps toward commercializing a isoflavone botanical product for treating alcoholism. Excessive use of alcohol accounts for much of the public health burden related to alcohol use disorders, including fetal alcohol syndrome, fatal motor crashes, accidents and homicides. On college campuses alone, alcohol use results annually in almost 2,000 deaths, 100,000 sexual assaults, 600,000 injuries, and 700,000 assaults. For most, problematic drinking and its associated morbidity will not be brought to the attention of Primary Care Professionals and so many go without treatment. This is precisely where an OTC herbal product could have the greatest impact. An extract of kudzu (Pueraria lobata) has been patented by McLean Hospital and licensed it to NPI under the name Alkontrol-herbal. Over the past 13 years, our team has extensively studied this kudzu extract and demonstrated its safety and efficacy in healthy control subjects as well as in heavy binge drinkers. The reason for pursuing the STTR mechanism is two-fold: 1) while NPI has been able to produce enough product for our modest clinical studies, they are not in a position to ramp up full production in order to support larger scale clinical trials; and 2) we have conducted and published 6 studies in human subjects, but we have yet to conduct a study in heavy drinkers who are alcohol-dependent and are treatment-seeking. Thus, there is a significant need for this clinical trial to demonstrate efficacy in this important population. The reason for the Fast Track approach is that we have already developed product, licensed it to NPI, and have the backbone of a commercialization plan, but need fiscal support to develop the processes needed to increase production of enough standardized product to support not only the clinical trial, but to be able to meet the needs once the commercialization plan is implemented. Thus Phase I will be focused on providing NPI with the infrastructure to scale up production of standardized, high quality Alkontrolherbal while the clinical trial will be the major milestone of Phase II. Collectively, successful completion of these two phases will pave the way for the commercialization of Alkontrol-herbal. Key milestones for Phase I include: procure and authenticate Pueraria lobata from our source in China, perform GMP extraction and precipitation, develop independent QC analytical protocols, optimize ratio of isoflavones, and finalize submission of an IND for FDA-approved labeling and IRB applications. Phase II milestones include: scale up production of Alkontrolherbal, isolate puerarin for standardization, develop a urinary biomarker for medication adherence and conduct proof-of-concept clinical trial in treatment-seeking alcohol-dependent individuals.

此快速通道 STTR 奖申请代表了 Natural Pharmacia 之间的合作 International, Inc. (NPI) 和麦克莱恩医院将采取措施将异黄酮植物药商业化 用于治疗酒精中毒的产品。过度饮酒是造成大部分公共健康负担的原因 酒精使用障碍，包括胎儿酒精综合症、致命车祸、事故和凶杀。在 仅在大学校园，酗酒每年就会导致近 2,000 人死亡、100,000 起性侵犯、 60万人受伤，70万人袭击。对于大多数人来说，有问题的饮酒及其相关的发病率不会 引起了初级保健专业人员的注意，许多人没有得到治疗。这正是 非处方草药产品可能产生最大影响的地方。葛根 (Pueraria lobata) 提取物 麦克莱恩医院 (McLean Hospital) 授予专利，并以 Alkontrol-herbal 名称授权给 NPI。过去13年里， 我们的团队对这种葛根提取物进行了广泛的研究，并证明了其在健康控制方面的安全性和有效性 受试者以及酗酒者。追求 STTR 机制的原因有两个：1）同时 NPI 已经能够为我们适度的临床研究生产足够的产品，但他们无法扩大规模 全面生产以支持更大规模的临床试验； 2) 我们已经进行并发表了 6 以人类为受试者的研究，但我们尚未对酒精依赖的重度饮酒者进行研究 并正在寻求治疗。因此，非常需要这项临床试验来证明这方面的功效 重要人群。采用快速通道方法的原因是我们已经开发了产品， 将其授权给 NPI，并拥有商业化计划的支柱，但需要财政支持来开发 增加足够标准化产品的生产所需的流程不仅可以支持临床试验， 但一旦商业化计划实施后能够满足需求。因此第一阶段将是 专注于为 NPI 提供基础设施，以扩大标准化、高质量 Alkontrolherbal 的生产 而临床试验将是II期的重要里程碑。共同顺利完成这些 两个阶段将为 Alkontrol-herbal 的商业化铺平道路。第一阶段的主要里程碑包括： 从我们在中国的来源采购和验证葛根，进行 GMP 提取和沉淀， 制定独立的QC分析方案，优化异黄酮的比例，并最终提交IND 用于 FDA 批准的标签和 IRB 应用。第二阶段的里程碑包括：扩大 Alkontrolherbal 的生产， 分离葛根素以实现标准化，开发药物依从性和行为的尿液生物标志物 在寻求治疗的酒精依赖个体中进行概念验证临床试验。