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.

这项快速通道STTR奖申请代表了Natural Pharmacia与 国际公司(NPI)和姆克林医院开始商业化的步骤， 一种治疗酒精中毒的药物。过度饮酒是造成公共卫生负担的主要原因， 酒精使用障碍，包括胎儿酒精综合症，致命的车祸，事故和杀人。对 仅在大学校园内，饮酒每年就导致近2，000人死亡、100，000起性侵犯， 60万人受伤，70万人被袭击。对于大多数人来说，问题饮酒及其相关的发病率不会被 引起了初级保健专业人员的注意，许多人没有得到治疗。这恰恰是 OTC草药产品可能产生最大影响的地方。已将葛根（Pueraria lobata）的提取物 专利的姆克林医院，并授权给NPI的名称Alkontrol草药。在过去的13年里， 我们的团队已经广泛地研究了这种提取物，并证明了它在健康控制中的安全性和有效性。 以及重度饮酒者。推行短期信托机制的原因有两方面： NPI已经能够为我们适度的临床研究生产足够的产品，他们没有能力增加 全面生产，以支持更大规模的临床试验;和2）我们已经进行并发表了6 在人类受试者中进行的研究，但我们还没有在依赖酒精的酗酒者中进行过研究 正在寻求治疗因此，非常需要这项临床试验来证明在这方面的疗效。 重要人口。之所以采用快速通道方法，是因为我们已经开发出了产品， 授权给NPI，并有一个商业化计划的骨干，但需要财政支持，以发展 增加足够标准化产品的生产所需的过程，不仅支持临床试验， 但一旦商业化计划实施，就能够满足需要。第一阶段将是 专注于为NPI提供基础设施，以扩大标准化，高质量的Alkontrolherb的生产 而临床试验将是第二阶段的重要里程碑。共同地，成功地完成这些 两个阶段将为Alkontrol-草药的商业化铺平道路。第一阶段的关键里程碑包括： 从我们在中国的来源采购和鉴定葛根，进行GMP提取和沉淀， 制定独立的QC分析方案，优化甾体酮的比例，并最终提交IND 用于FDA批准的标签和IRB申请。第二阶段的里程碑包括：扩大Alkontrolherbal的生产， 分离葛根素用于标准化，开发药物依从性和行为尿生物标志物 在寻求治疗的酒精依赖个体中进行的概念验证临床试验。