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

项目（摘要（/）摘要（ 滥用处方药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 根据美国药物滥用协会的数据， 药物成瘾。 战胜流行病的最好方法是减少接触。在这种情况下，挑战在于 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 这既满足了个别患者的需求，也解决了全国阿片类药物的流行问题。 Elysium的O2 P（口服过量保护）技术旨在提供这样一种 平衡的解决方案，利用现有的 阿片类药物，同时防止滥用和致命的过量。使用新的化学，我们 创造了一类新的速释（IR）口服阿片类药物， 替代广泛使用的Vicodin®、Percocet®、Lortab®、诺科®等， 上级防篡改和前所未有的口服过量保护，可以： 每年拯救成千上万的生命; ·中断滥用造成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 ·为世界各地目前无法缓解疼痛的患者提供安全的疼痛缓解 由于担心滥用而获得有效的基于阿片类药物的疼痛治疗 还有吸毒过量 在NIH和NIDA的支持下（1 R44 DA 037900），Elysium成功实现了 体内概念验证。这项拟议赠款的总体目标是与 由高素质的CRO和科学顾问组成的战略联盟， 我们的O2 P IR氢可酮候选产品的开发通过1期人体试验 概念验证研究，这是推进我们领先FDA批准的关键一步， 以及与一家大型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.