Novel opioids that protect against oral overdose and disrupt the progression to misuse, abuse, and addiction

项目(摘要/(摘要( 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。2014年，处方阿片类药物导致 根据美国医学会的数据，美国有18893人死于服药过量 上瘾医学。 战胜流行病的最好方法是减少接触。在这种情况下，挑战是 在不影响病人护理的情况下减少暴露。这需要一个平衡的解决方案。 这既解决了个别患者的需求，也解决了全国范围内的阿片类药物流行。 极乐的O2P(口服过量保护)技术旨在提供这样的 平衡解决方案，充分利用现有的 阿片类药物，同时防止滥用和致命的过量用药。使用新的化学，我们 已经创造了一类新的即刻释放(IR)口服阿片类药物，提供了一种诱人的 替代广泛使用的Vicodin®、Perdicet®、Lortab®、Norco®等 卓越的防篡改性能和前所未有的口服过量保护功能，可： ·每年拯救数以千计的生命； ·阻断因滥用和滥用而导致的令人心碎且往往致命的进展 滥用处方阿片类药物、海洛因使用和成瘾；以及 ·为世界各地的患者提供安全的止痛药，但目前还不能 由于对滥用的恐惧而获得有效的阿片类药物疼痛治疗 还有服药过量。 在NIH和NIDA的支持下(1R44DA037900)，极乐空间成功地实现了 活体概念验证。这项拟议拨款的总体目标是与 由高素质CRO和科学顾问组成的战略联盟加速 我们的O2P IR氢可酮候选产品在人类第一阶段的开发 概念验证研究，这是推动我们取得FDA批准的关键一步， 以及与一家更大的制药公司的商业化交易。

Project(Summary(/(Abstract( The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. In 2014, prescription opioids caused 18,893 overdose deaths in the United States, according to the American Society of Addiction Medicine. The best way to defeat an epidemic is to reduce exposure. In this case, the challenge is to reduce exposure without compromising patient care. This calls for a balanced solution that addresses both the individual patient's needs and the national opioid epidemic. Elysium’s O2P (oral overdose protection) technology is designed to provide such a balanced solution by taking advantage of the well-established efficacy of existing opioids, while protecting against abuse and fatal overdose. Using novel chemistry, we have created a new class of immediate-release (IR) oral opioids that offer an attractive alternative to the widely-prescribed Vicodin®, Percocet®, Lortab®, Norco®, etc. with superior tamper resistance and unprecedented protection from oral overdose that could: · Save thousands of lives each year; · Disrupt the heartbreaking and often lethal progression from the misuse and abuse of prescription opioids, to heroin use and addiction; and · Provide safe pain relief to patients throughout the world that currently do not have access to effective opioid-based pain therapy due to fears relating to abuse and overdose. With NIH and NIDA’s support (1R44DA037900), Elysium has successfully achieved in vivo proof-of-concept. The overall goal of this proposed grant is to collaborate with a Strategic Alliance of highly qualified CROs and scientific advisers to accelerate development of our O2P IR hydrocodone product candidate through Phase 1 human proof of concept studies, a pivotal step toward advancing our lead toward FDA approval, and a commercialization deal with a larger pharmaceutical company.