Bio-Activated Opioid Drugs with Unprecedented Oral and Non-Oral Abuse-Resistance

描述：处方药滥用是美国增长最快的毒品问题，减少这种滥用是国家的优先事项。虽然阿片类药物最普遍的滥用途径之一是口服途径，但目前基于配方和分子的技术主要用于抵抗非口服途径（例如吸入和注射）的滥用。因此，这些方法不能充分解决口服滥用和过量（即，多种药片的共同摄入），可以很容易地通过直接提取技术挫败。为了解决美国处方药误用、滥用和过量流行的问题，需要开发全面、有力的抗滥用技术，最好适用于所有处方阿片类药物。为此，我们建议从一类独特的专有分子中获得至少一种候选产品，用于ind研究，这些分子旨在提供有效的阿片类药物疼痛缓解，具有前所未有的保护，免受所有滥用途径的侵害。我们正在申请快速通道，因为NIDA项目官员向我们保证，我们提议的项目是一个优秀的快速通道候选者，基于：我们的首席研究员领导的令人信服的体外和体内研究数据证明了可行性；目前基于配方的技术不能有效解决口服误用、滥用和过量；关键利益相关者（即潜在的大型制药合作伙伴-用于开发和商业化，关键意见领袖，开处方的医生和患者）对我们的技术表达了浓厚的兴趣。

DESCRIPTION: The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. While one of the most prevalent routes of abuse for opioid medicines is the oral route, current formulation- and molecular-based technologies are primarily designed to resist abuse via non-oral routes (e.g., inhalation and injection). Consequently, these approaches fail to adequately address oral abuse and overdose (i.e., co-ingestion of multiple pills), and can be easily thwarted by straightforward extraction techniques. To address the nation's prescription drug misuse, abuse, and overdose epidemics, comprehensive, robust abuse-resistance technologies need to be developed and, ideally, applied to all prescription opioid drugs. To that end, we propose to qualify at least one product candidate for IND-enabling studies from a unique class of proprietary molecules designed to provide effective opioid-based pain relief, with unprecedented protection from all routes of abuse. We are applying for Fast-Track because NIDA program officials assured us that our proposed project is an excellent Fast-Track candidate based on: Compelling in vitro and in vivo data from studies led by our Principal Investigator demonstrate feasibility; Current formulation-based technologies do not effectively address oral misuse, abuse, and overdose; and Key stakeholders (i.e., potential large pharmaceutical partners - for development and commercialization, key opinion leaders, prescribing physicians, and patients) have expressed strong interest in our technology.