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

产品说明：Elysium发现了一种新的分子失活（XpiRx或“过期药丸”）技术，旨在有效遏制未使用的处方阿片类药物的广泛滥用和转移。使用Elysium的技术，阿片类药物产品将在规定的使用期限之外的指定时间窗口内安全且不可逆地失去其效力，使其缺乏阿片类激动剂作用，因此完全抗滥用。我们的XpiRx技术能够：（i）在规定的使用期内有效缓解疼痛;（ii）通过非口服途径抗滥用;（iii）在规定的使用期后口服滥用威慑;以及（iv）在计划的有效期后口服过量保护。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，而且主要是由一个不太可能的来源--美国人的药柜--造成的。“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仅损失约1%的效力，导致70年的效力半衰期。Elysium的XpiRx技术大大缩短了阿片类药物的效力半衰期，这将大大减少吸引滥用者的药物池（“转移池”）。我们正在申请快速通道，因为NIDA项目官员向我们保证，我们提出的项目是一个优秀的快速通道候选人，基于：从我们的主要研究者领导的研究中获得的令人信服的体外数据，加上已发表的1期人体数据，证明了XpiRx技术实现前所未有的抗滥用和抗转移的可行性;开发中或市场上缺乏解决滥用处方类阿片药物的主要来源-转移的技术;以及关键利益攸关方的利益：国家药物管制政策办公室（ONDCP）和国家药物滥用研究所（NIDA）已将转移确定为一个高度优先的问题，因为它助长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的标准安全要求（如汽车安全气囊）。

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).