Development of a 3-month implantable depot pellet of Naltrexone for the treatment of Opioid Use Disorder.

BioCorRx正在开发BICX102，这是阿片类拮抗剂纳曲酮(NTX)的一种皮下固体库丸。 NTX是治疗阿片类药物使用障碍(OUD)的有效药物。单次BICX102植入将提供持续的 阿片受体阻断长达3个月。这可以防止患者受到 几乎任何阿片类药物复发事件，同时提高疗效和坚持支持 长期管理和恢复。如果发生药物不良反应，BICX102微丸可以被移除。 BICX102是通过505(B)2 FDA途径开发的，因为NTX和其他成分已经 由FDA单独批准；BICX102已作为Prodeoxone®用于&gt；12在俄罗斯临床使用 好几年了。这份UG3-UH3提案包括获得FDA批准的步骤。200多万美国人 ODS，约有42,000人死于阿片类药物过量(2016年)。2015年，阿片类药物的流行造成了5040亿美元的损失。~91% 那些处于恢复期的人会复发，80%的人会在一个月内复发。长期禁欲很难 由于对有效治疗的依从性较差，如NTX片剂和每月注射。我们的创新 解决方案是BICX102：一种安全有效的3个月皮下埋藏颗粒/植入物，含有NTX(1000 Mg)，这对患者依从性的依赖程度较低。FDA的指导意见表明，他们可能会依赖于我们提出的 关于BICX102及其成分的研究和现有数据是505(B)2批准的基础。BioCorRx有一个 阿片类药物治疗、监管、CMC、非临床、临床开发和监管事务专家团队 使用拟议研究中经常使用的优秀设施来完成此项目。目标1： 化学制造和控制(CMC)：BICX102；配方综合计划 开发、技术转让、临床批量生产、FDA注册批量生产和 稳定性测试。交付成果1：建立GMP设施生产药品(3个月纳曲酮/TCA 植入物)，用于研发和商业化。目标2：关键的GLP安全性和药代动力学 BICX102、Revia和Kenalog的研究。交付件2：向FDA提交IND申请以供审查。 UG3过渡里程碑：FDA成功批准IND进入临床阶段。目标 3.3个月BICX102纳曲酮库单剂量和多剂量药代动力学比较 可交付物3：纳曲酮血清浓度高于1-2 ng/ml的缓释药物，最长可持续3个月。UH3 里程碑：向FDA提交505(B)2 NDA申请以获得上市批准。结论：获得 BICX102迅速推向市场是国家的优先事项，需要有效和及时的互动 在BioCorRx和FDA之间。这项里程碑式的拨款提案之所以突出，是因为它遵循了 505(B)2已被FDA认为可接受以获得批准的监管路径。我们从 广泛的非临床和临床研究表明，BICX102将是有效的。这笔赠款将导致批准 BICX102在第四年获得职位奖。

BioCorRx is developing BICX102, a subcutaneous solid depot pellet of the opioid antagonist naltrexone (NTX). NTX is a proven treatment for opioid use disorder (OUD). A single BICX102 implantation will provide continual blockade of opioid receptors for up to 3 months. This can prevent patients from being affected adversely by almost any opioid relapse event, while improving efficacy and adherence to behavioral programs that support long term management and recovery. The BICX102 pellet can be removed if adverse drug reactions occur. BICX102 is being developed via the 505(b)2 FDA pathway as NTX and the other ingredients have been approved individually by the FDA; and BICX102 has been in clinical use in Russia as Prodetoxone® for >12 years. This UG3-UH3 proposal comprises the steps to achieve FDA approval. 2 million+ Americans have OUDs, with ~42,000 opioid overdose deaths (2016). The opioid epidemic cost $504 billion in 2015. ~91% of those in recovery experience relapse, and 80% do so within one month. Long-term abstinence is difficult to achieve due to poor compliance to effective therapies like NTX tablets and monthly injections. Our innovative solution is BICX102: a safe and effective 3-month subcutaneous depot pellet/implant containing NTX (1000 mg) that is less reliant on patient compliance. FDA guidance has indicated that they may rely on our proposed studies and existing data on BICX102 and its ingredients for the basis for 505(b)2 approval. BioCorRx has a team of experts in opioid treatment, regulation, CMC, nonclinical, clinical development and regulatory affairs to complete this project using outstanding facilities that are routinely used in the studies proposed. Aim 1: Chemistry Manufacturing and Controls (CMC): BICX102; Comprehensive Plan for Formulation Development, Technology Transfer, Clinical Batch Manufacture, FDA Registration Batch Manufacture and Stability Testing. Deliverable 1: Establish GMP facility to manufacture drug product (3-month Naltrexone/TCA Implant) for research and development and commercialization. Aim 2: Pivotal GLP Safety, Pharmacokinetic Study of BICX102, Revia, and Kenalog. Deliverable 2: Submission of IND application to the FDA for review. UG3 Transition Milestone: Successful approval of the IND by the FDA to proceed to the clinical stage. Aim 3: Comparative Single and Multiple Dose Pharmacokinetics of 3-month BICX102 Naltrexone Depot. Deliverable 3: Sustained release naltrexone serum levels above 1-2 ng/ml for up to 3 months. UH3 Milestone: Submission of 505(b)2 NDA application to FDA for marketing approval. Conclusion: Getting BICX102 to the market quickly is a national priority which necessitates effective and timely interactions between BioCorRx and the FDA. This milestone driven grant proposal is outstanding because it is following a 505(b)2 regulatory path that has been deemed acceptable by the FDA to achieve approval. We know from extensive non-clinical and clinical studies that BICX102 will be effective. This grant will result in the approval of BICX102 in Year 4 post award.