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.

美国仍然牢牢掌握着成瘾和过量的渐进式阿片类药物危机。2019年，近 5万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开发纳洛酮透皮贴剂的计划将解决多种HEAL 通过提供新的预防和治疗替代方案，优化目前的药物辅助， 治疗和改善获得治疗的机会。 拮抗剂纳洛酮是仅有的三种在OUD复发预防中具有证明益处的药物之一。 由于口服形式的耐受性和依从性较差，肌内（IM）纳洛酮是唯一可行的拮抗剂 在OUD人群中选择。尽管在2010年获得批准，但规定不到3万人 美国的病人每年。患者摄取受限于可用性、给药方式（护士- 给予4 mL臀部深部注射）、成本和低依从性。利伯罗已经召集了一个高度 经验丰富的团队将一种新型纳洛酮透皮贴剂（NNTP）推向市场，该贴剂与 IM纳洛酮的好处在于它是非成瘾性的，避免了首过代谢， 不容忍除了作为预防OUD复发的一种易于使用的替代方案外，NNTP还提供了一种 对于希望远离慢性疾病的稳定患者来说， 激动剂的使用，以及在复发风险中与渴望作斗争的停药患者。NNTP将消除 管理负担、患者不适和目前限制IM纳洛酮使用的成本障碍。 这为NNTP在初级保健中的广泛使用提供了一个真正的机会， 类阿片依赖者迫切需要护理。 该计划已被告知明确输入从FDA，无论是在血浆纳洛酮水平 要求和必要的监管措施。Libero将寻求505（B）（2）途径，将NNTP带到 预防OUD复发的市场。UG 3阶段将包括IND使能活动，以确保FDA UH 3阶段将在多中心、双中心和多中心的研究中评价NNTP的疗效和安全性。 与IM纳洛酮比较的盲法、随机对照试验，为期6个月。