Abuse-deterrent sustained-release hydromorphone

描述（由申请人提供）：缓释麻醉药品受到吸毒者的高度追捧，因为它们比速释制剂提供更强大的欣快感。药物滥用者很容易破坏其缓释特性，然后摄入、鼻吸或注射麻醉药物，以获得即时的强效毒品快感。近年来，羟考酮（普渡制药公司的“奥施康定”）的滥用及其对公众健康和安全的风险已被高度宣传。2005年，普渡制药公司计划推出缓释氢吗啡酮，一种比羟考酮更有效的麻醉剂。这种新的缓释氢吗啡酮产品预计与奥施康定片剂具有相同的滥用漏洞。这些滥用的脆弱性，再加上氢吗啡酮比羟考酮效力更大，可能造成麻醉品滥用的潜在公共健康风险，其程度可能超过奥施康定。在本申请中，Pain Therapeutics, Inc.提出了一种基于专利的口服缓释剂型技术的防滥用氢吗啡酮缓释产品的初步配方工作。Pain Therapeutics公司目前正在开发一种类似的抗滥用羟考酮缓释制剂，目前正处于I期临床试验阶段。由于不能粉碎，这种制剂具有很强的抗滥用性，其12小时羟考酮剂量不能从包括酒精在内的普通饮料中提取。这项建议的目的是使用相同的技术来开发一种长效氢吗啡酮制剂，这种制剂同样抵抗滥用，但将提供长效疼痛缓解。

DESCRIPTION (provided by applicant): Sustained-release narcotic drugs are highly sought after by drug abusers because they provide a much more powerful euphoric high than immediate-release formulations. Drug abusers easily defeat the sustained-release feature then ingest, snort or inject the narcotic drug for an immediate and potent drug high. The abuse of oxycodone (Purdue Pharma's "OxyContin(tm)") and the resulting risk to public health and safety has been highly publicized in recent years. In 2005, Purdue Pharma plans to launch sustained-release hydromorphone, a more potent narcotic than oxycodone. This new, sustained-release hydromorphone product is expected to have the same abuse vulnerabilities as OxyContin tablets. These abuse vulnerabilities, combined with the greater potency of hydromorphone compared to oxycodone, may create a potential public health risk from narcotic abuse of a magnitude that could exceed that of OxyContin. In this application, Pain Therapeutics, Inc. proposes initial formulation work for an abuse-deterrent sustained-release hydromorphone product that will be based upon a patented, sustained-release oral dosage form technology. Pain Therapeutics, Inc. is currently developing a similar abuse-deterrent sustained-release formulation of oxycodone, which is in Phase I clinical trials. This formulation is highly resistant to abuse as it cannot be crushed, and its 12-hour oxycodone dose cannot be extracted in common beverages including alcohol. The aim of this proposal is to use the same technology to develop a sustained-release hydromorphone formulation that similarly resists abuse yet will provide long-acting pain relief.