Unprecedented Diversion-/Abuse-Resistance: Molecular Deactivation of Opioid Drugs

描述：极乐公司发现了一种新的分子失活(XpiRx)技术，该技术旨在有效地遏制未使用的处方阿片类药物的广泛滥用和转移。使用极乐公司的技术，阿片类药物产品将在超过规定使用期的特定时间窗口内安全且不可逆转地失去效力，使它们失去阿片激动剂作用，因此完全耐滥用。我们的XpiRx技术能够：(I)在规定的使用期内有效缓解疼痛；(Ii)通过非口服途径抵抗滥用；(Iii)口腔滥用--阻止超过规定的使用期；以及(Iv)超过程序的有效期后的口服过量保护。根据奥巴马总统的说法，“处方药滥用是美国增长最快的毒品问题，而且很大程度上是由一个不太可能的来源--美国人的药柜--助长的。”超过70%的滥用者从朋友和家人那里获得未使用的处方阿片类药物。目前的阿片类药物每年只损失约1%的效力，导致70年的效力半衰期。极乐的XpiRx技术大大缩短了阿片类药物的效力半衰期，这将大大减少吸引吸毒者的药物池(“分流池”)。我们申请Fast-Track是因为NIDA项目官员向我们保证，我们建议的项目是一个极好的Fast-Track候选项目，基于以下因素：由我们的首席调查员领导的研究的令人信服的体外数据，加上已公布的第一阶段人体数据，证明了利用XpiRx技术实现前所未有的抗滥用和转用的可行性；缺乏解决转用的技术，转用是滥用处方阿片类药物的主要来源；以及关键利益相关者的兴趣：国家药物管制政策办公室(ONDCP)和国家药物滥用研究所(NIDA)已将转用确定为高度优先的问题，因为它加剧了处方药滥用的流行。制药公司领导人认为，XpiRx可能成为阿片类药物(如汽车安全气囊)的标准安全要求。

DESCRIPTION: Elysium has discovered a novel molecular deactivation (XpiRx" or "expiring pill") technology that is designed to effectively curb the widespread abuse and diversion of unused prescription opioid drugs. Using Elysium's technology, opioid drug products will safely, and irreversibly lose their potency over a specified time window beyond the prescribed use period, rendering them devoid of opioid agonist effects, and, therefore, completely abuse-resistant. Our XpiRx technology enables: (i) effective pain relief during the prescribed use period; (ii) abuse-resistance via non-oral routes; (iii) oral abuse-deterrence beyond the prescribed use period; and (iv) oral overdose protection beyond the programmed expiration date. According to President Obama, "Prescription drug abuse is America's fastest-growing drug problem, and one largely fed by an unlikely source - Americans' medicine cabinets." Over 70% of abusers obtain unused prescription opioids from their friends and family. Current opioid pills lose only ~1% of their potency per year, resulting in a 70-year potency half-life. Elysium's XpiRx technology dramatically shortens the opioid drug's potency half-life, which would substantially decrease the pool of drugs ("diversion pool") that attract abusers. 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 data from studies led by our Principal Investigator coupled with published Phase 1 human data demonstrate the feasibility of achieving unprecedented abuse- and diversion-resistance with XpiRx technology; The lack of technologies in development or on the market that address diversion, the primary source for abused prescription opioid drugs; and Key stakeholder interest: The Office for National Drug Control Policy (ONDCP) and The National Institute on Drug Abuse (NIDA) have identified diversion as a high priority issue because it fuels the prescription drug abuse epidemic. Pharmaceutical company leaders believe that XpiRx could become a standard safety requirement for opioid drugs (like airbags for automobiles).