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

基本信息

批准号：
10616580
负责人：
Andrew Gardiner
金额：
$ 318.75万
依托单位：
LIBERO PHARMA LIMITED
依托单位国家：
美国
项目类别：
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/10616580
关键词：
Address Adherence Agonist Authorization documentation Behavioral Biological Assay Caring Cavia Chronic Clinical Clinical Research Communities 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 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 Health Care Protocols documentation Randomized Controlled Trials Regulatory Pathway Relapse Risk Safety Secure Site Solid Specialist Toxicology Training Underserved Population United States United States Food and Drug Administration addiction alternative treatment antagonist benefit sharing clinical development cost cost effective craving disorder later incidence prevention drug development efficacy evaluation experience grasp healthy volunteer irritation medication-assisted treatment novel opioid epidemic opioid overdose opioid use disorder preclinical study prevent programs psychologic relapse risk targeted treatment trial comparing uptake

项目摘要

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.

2019 年，美国仍深陷阿片类药物成瘾和过量服用危机。 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 开发纳曲酮透皮贴剂的计划将解决多种治愈问题通过提供新的预防和治疗替代方案、优化当前的药物辅助来实现目标治疗，并改善获得治疗的机会。拮抗剂纳曲酮是仅有的三种已被证明可预防 OUD 复发的药物之一。由于口服形式的耐受性和依从性较差，肌肉注射 (IM) 纳曲酮是唯一可行的拮抗剂尽管在 2010 年获得批准，但该方案的适用人数不足 30,000 人。在美国，患者每年接受的治疗受到可用性、给药方式（护士）的限制。 Libero 的给药方式（4mL 臀部深部注射）成本高，依从性低。经验丰富的团队将新型纳曲酮透皮贴剂 (NNTP) 推向市场，该贴剂具有 IM 纳曲酮的优点在于它不成瘾，并且避免首过代谢及其结果除了一种易于使用的预防 OUD 复发的替代方案外，NNTP 还提供了一种预防不耐受的方法。对于希望摆脱慢性病最后一步的病情稳定的患者来说，这是一个可行且令人畏惧的选择 NNTP 将消除兴奋剂的使用，以及与药物渴望作斗争的患者。目前限制肌内注射纳曲酮使用的行政负担、患者不适和成本障碍。这为在初级保健中广泛使用 NNTP 提供了真正的机会，在初级保健中，阿片类药物依赖人群迫切需要护理。该计划已根据 FDA 的明确意见提供信息，包括血浆纳曲酮水平 Libero 将采取 505(b)(2) 途径将 NNTP 引入。 UG3 阶段将包括 IND 支持活动，以确保获得 FDA 批准。 UH3 阶段将在多地点、双中心评估 NNTP 的有效性和安全性。针对 IM 纳曲酮比较剂的为期 6 个月的盲法随机对照试验。