Naltrexone Transdermal Patch - An Accessible, Patient-Focused Option to Treat OUD Relapse

纳曲酮透皮贴剂 - 一种以患者为中心、易于使用的治疗 OUD 复发的选择

• 批准号: 10708991
• 负责人: Andrew Gardiner
• 金额: $ 316.35万
• 依托单位: LIBERO PHARMA LIMITED
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10708991
• 关键词: Adherence; Agonist; Authorization documentation; Behavioral; Biological Assay; Caring; Cavia; Chronic; Clinical; Clinical Research; Community Healthcare; Cyclic GMP; Data; Development; Double-Blind Method; Drug Kinetics; Drug Stability; European Union; Exercise; Face; Formulation; Foundations; Goals; Health Services Accessibility; Human; Hypersensitivity; Illicit Drugs; Improve Access; Injections; Intramuscular; Intramuscular Injections; Marketing; Measures; Medicine; Metabolism; Methods; Miniature Swine; Naltrexone; Nurses; Opiate Addiction; Oral; Overdose; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Plasma; Population; Prevention; Primary Care; Productivity; Protocols documentation; Randomized, Controlled Trials; Regulatory Pathway; Relapse; Risk; Safety; Secure; Self Management; Site; Solid; Specialist; Toxicology; Training; Underserved Population; United States; United States Food and Drug Administration; addiction; alternative treatment; antagonist; authority; benefit sharing; clinical development; cost; cost effective; craving; drug development; efficacy evaluation; experience; grasp; healthy volunteer; irritation; manufacture; medication-assisted treatment; novel; nursing administration; opioid epidemic; opioid overdose; opioid use disorder; preclinical study; programs; psychologic; relapse prevention; relapse risk; targeted treatment; trial comparing; uptake

The U.S. remains firmly in the grip of a progressive opioid crisis of addiction and overdose. In 2019 nearly 50,000 people died of an opioid overdose and an estimated 3 million people have Opioid Use Disorder (OUD). Libero Pharma’s program to develop a naltrexone transdermal patch will address multiple HEAL objectives by providing new prevention and treatment alternatives, optimizing current medication-assisted therapy, and improving access to treatment. The antagonist naltrexone is one of only three medications with proven benefit in OUD relapse prevention. With poor tolerance and compliance in oral form, intramuscular (IM) naltrexone is the only viable antagonist option in the OUD population. Despite being approved in 2010, it is prescribed to fewer than 30,000 patients in the U.S. annually. Patient uptake is limited by availability, mode of administration (nurse- administered 4mL deep gluteal injection), cost, and low adherence. Libero has assembled a highly experienced team to bring to market a novel naltrexone transdermal patch (NNTP), which shares the benefits of IM naltrexone in that it is non-addictive and avoids first-pass metabolism and the resultant intolerance. As well as an easy-to-use alternative in OUD relapse prevention, NNTP also offers an accessible and undaunting option both for stable patients looking to take the final step away from chronic agonist use, and off-drug patients struggling with cravings at risk of relapse. The NNTP would eliminate the administrative burden, patient discomfort, and cost barriers that currently limit the use of IM naltrexone. This presents a genuine opportunity for widespread NNTP use in primary care where a vast and growing opioid-dependent population urgently requires care. This programme has been informed by clear input from the FDA, both in terms of plasma naltrexone level requirements and the required regulatory steps. Libero will pursue a 505(b)(2) pathway to bring NNTP to market for OUD relapse prevention. The UG3 Phase will include IND-enabling activities to secure an FDA issuance of an IND. The UH3 Phase will evaluate efficacy and safety of the NNTP in a multi-site, double- blind, randomized controlled trial against the IM naltrexone comparator over 6 months.

美国首先仍处于进步的阿片类药物成瘾和过量危机中。在2019年几乎 50,000人死于阿片类药物过量，估计有300万人患有阿片类药物使用障碍 （OUD）。 Libero Pharma开发纳曲酮透皮贴片的计划将解决多个治疗 通过提供新的预防和治疗替代方案，优化当前药物辅助的目标 治疗，并改善获得治疗的机会。 拮抗剂纳曲酮是仅有的三种具有可靠救济效果的药物之一。 肌肉内（IM）纳曲酮的耐受性和依从性较差，是唯一可行的拮抗剂 OUD人口中的选项。尽管在2010年获得批准，但规定了不到30,000 每年在美国的患者。患者的摄取受到可用性，管理方式的限制（护士 - 给予4毫升深臀注射），成本和低粘附性。 Libero聚集了高度 经验丰富的团队可以推销一种新颖的纳曲酮透明膜贴片（NNTP），该补丁（NNTP）分享了 Im Naltrexone的好处是，它是非添加的，并且避免了首次代谢和结果 intlerance。除了预防Oud浮雕方面易于使用的替代方案，NNTP还提供了 对于希望远离慢性的稳定患者，稳定的患者都可以访问且不敢的选择 激动剂的使用，而在渴望退休风险的渴望中挣扎。 NNTP将消除 行政伯恩，患者不适以及目前限制使用IM Naltrexone的成本障碍。 这为宽度NNTP在初级保健中的使用提供了真正的机会 阿片类药物依赖性人群紧急需要护理。 该程序已通过FDA的明确输入告知，无论是等离子体纳曲酮级别而言 要求和所需的监管步骤。 Libero将追求505（b）（2）途径，将NNTP带到 OUD救济预防市场。 UG3阶段将包括确保FDA的成熟活动 发行印度。 UH3阶段将评估NNTP在多站点的双位置中的有效性和安全性 在6个月内针对IM Naltrexone比较器的盲，随机对照试验。