Naltrexone Hydrochloride

Former Acting Director of the White House Office of National Drug Control Policy Brings 28 Years of Federal Drug Policy and Addiction Expertise to BioCorRx ANAHEIM, CA - September 10, 2026 (NEWMEDIAWIRE) - BioCorRx Inc. (OTC: BICX) (the "Company"), a developer and provider of innovative treatment support programs for substance use disorders and related conditions, today announced the appointment of Richard J. Baum to the Company's Strategic Advisory Board. Baum is a former Acting Director of the White House Office of National Drug Control Policy (ONDCP) and former Executive Director of the President's Commission on Combating Drug Addiction and the Opioid Crisis. Baum brings nearly three decades of experience in national drug policy, addiction, public health, law enforcement, and justice policy. During 28 years at ONDCP, he served across six presidential administrations and helped shape federal responses to evolving drug threats, including the opioid crisis. His experience spans treatment and recovery policy, prevention, public safety, interagency coordination, and collaboration with state and local partners. BioCorRx Inc. expects to draw on Baum's policy and systems-level expertise as the Company advances its treatment and pharmaceutical strategies, including LUCEMYRA® (lofexidine), an FDA-approved non-opioid medication indicated for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults, and BICX104, the Company's investigational biodegradable naltrexone implant technology. His perspective will also support the Company's engagement with treatment and recovery organizations, public health agencies, healthcare systems, justice-system partners, policymakers, and other stakeholders addressing substance use, withdrawal management, and related public health challenges. "Rich has spent his career at the intersection of drug policy, public health, treatment, and public safety, and we are honored to welcome him to BioCorRx," said Lourdes Felix, Chief Executive Officer of BioCorRx Inc. "His deep understanding of how policy translates into real-world treatment access will be invaluable as we work to expand awareness of evidence-based approaches to addiction treatment and thoughtfully position our programs within the broader continuum of care." "I am pleased to join BioCorRx as a strategic advisor at a time when the country continues to face significant challenges related to opioid use, addiction treatment, and recovery," said Richard J. Baum. "BioCorRx is working across several important points in the treatment continuum, including managing opioid withdrawal symptoms with LUCEMYRA. In an era of increasingly dangerous polysubstance use, particularly involving illicit fentanyl and methamphetamine, I am also encouraged by the Company's research evaluating BICX104, an investigational long-duration naltrexone implantable pellet, as a potential treatment for methamphetamine use disorder. I look forward to helping BioCorRx position these approaches within a comprehensive, evidence-based system of care that expands treatment access, supports retention, and improves long-term recovery." About Richard J. Baum Richard J. Baum is a nationally recognized drug policy leader, author, educator, speaker, and strategic advisor. During 28 years at the White House Office of National Drug Control Policy, he served across six presidential administrations and played a leading role in developing six National Drug Control Strategies. His senior positions included Acting Director of ONDCP and Executive Director of the President's Commission on Combating Drug Addiction and the Opioid Crisis. Baum is an Adjunct Professor at Georgetown University's McCourt School of Public Policy and the author of Inside America's Opioid Crisis: 12 Hard Lessons for Today's Drug War. He also serves on the United Against Fentanyl Board of Directors. His work focuses on improving addiction treatment and recovery, strengthening public health and public safety collaboration, and developing more effective responses to opioid, synthetic-drug, and polysubstance-use threats. His recent writing on the opioid crisis has also appeared in The Lancet. About BioCorRx Inc. BioCorRx Inc. (OTC: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app and medication prescribed by an independent treating physician at their discretion. The UnCraveRx® Weight Loss Program is a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts, and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. BioCorRx also operates through its subsidiary, BioCorRx Pharmaceuticals Inc., which focuses on pharmaceutical commercialization and development, including LUCEMYRA® (lofexidine) - an FDA-approved medication indicated to mitigate opioid withdrawal symptoms in adults - and the development of BICX104, an investigational biodegradable naltrexone implant technology. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com. About LUCEMYRA® (lofexidine) LUCEMYRA® (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. In clinical trials, LUCEMYRA® reduced the severity of withdrawal symptoms compared to placebo, as reported by patients experiencing opioid withdrawal. LUCEMYRA® is administered orally for up to 14 days, with dosing guided by symptoms. LUCEMYRA® should be discontinued with gradual dose reduction over two to four days. The most common adverse reactions are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. Important Safety Information What is LUCEMYRA? LUCEMYRA® is a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly. LUCEMYRA® will not completely prevent the symptoms of opioid withdrawal and is not a treatment for opioid use disorder. LUCEMYRA® can cause serious side effects, including low blood pressure, slow heart rate, and fainting. Watch for symptoms of low blood pressure or heart rate, including dizziness, lightheadedness, or feeling faint at rest or when quickly standing up; if you experience these symptoms, call your healthcare provider right away and do not take your next dose of LUCEMYRA® until you have talked to your healthcare provider. Avoid becoming dehydrated or overheated and be careful not to stand up too suddenly from lying or sitting, as these may increase your risk of low blood pressure and fainting. When your treatment is complete, you will need to stop taking LUCEMYRA® gradually, or your blood pressure could increase. After a period of not using opioid drugs, you can become more sensitive to the effects of opioids if you start using them again. This may increase your risk of overdose and death. Before taking LUCEMYRA® , tell your healthcare provider about all your medical conditions, including if you have low blood pressure, slow heart rate, any heart problems including history of heart attack or a condition called long QT syndrome, liver or kidney problems, or if you drink alcohol. Tell your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding; it is not known if LUCEMYRA® can harm your unborn baby or whether LUCEMYRA® passes into your breast milk. Especially tell your healthcare provider if you take benzodiazepines, barbiturates, tranquilizers, or sleeping pills, as taking these with LUCEMYRA® can cause serious side effects. The most common side effects of LUCEMYRA® include low blood pressure or symptoms of low blood pressure such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact BioCorRx Pharmaceuticals Inc. at 1-833-LUCEMYRA. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Click here to see full Prescribing Information. About BICX104 BICX104 is BioCorRx's investigational biodegradable naltrexone implant technology designed to provide controlled delivery of naltrexone. A prior clinical study evaluating the Company's implant technology was completed in 2023 (ClinicalTrials.gov Identifier: NCT04828694). A new clinical study evaluating BICX104 commenced in January 2026 (ClinicalTrials.gov Identifier: NCT07269873), with additional studies planned. The current clinical study is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health under Award Number U01DA059994. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Prior research evaluating the Company's implant technology was also supported in part by the National Institute on Drug Abuse. About Naltrexone Naltrexone is an opioid receptor antagonist that blocks the effects of opioids at the mu-opioid receptor. It has been approved by the U.S. Food and Drug Administration (FDA) in oral and extended-release injectable forms for the treatment of opioid use disorder and alcohol dependence. By blocking opioid receptors, naltrexone can prevent the euphoric and sedative effects of opioids. Naltrexone has also been studied for potential use in other conditions, including substance use and metabolic disorders. About Methamphetamine Use Disorder Methamphetamine use disorder is a serious public health concern. Methamphetamine is a highly addictive central nervous system stimulant that can have significant health consequences. According to the 2025 National Survey on Drug Use and Health released this year, approximately 2.7 million people in the United States aged 12 or older reported using methamphetamine in the past year, while over 15 million have used methamphetamine at least once in their lifetime. Methamphetamine misuse has been associated with a range of adverse health effects, including cognitive impairment, psychiatric symptoms such as anxiety and psychosis, damage to the cardiovascular system, and severe dental disease. BioCorRx is conducting an ongoing NIDA-supported clinical study of BICX104, alone and in combination with bupropion, as a potential treatment for methamphetamine use disorder. About OUD Opioid Use Disorder (OUD) is a chronic and relapsing medical condition characterized by the problematic use of opioid drugs despite harmful consequences. Opioids are medications commonly prescribed for pain relief that act on the central nervous system and may produce both analgesic effects and feelings of euphoria. OUD can develop through misuse of prescription opioid medications, use of diverted prescription opioids, or use of illicit opioids such as heroin or illegally manufactured fentanyl. According to the 2025 National Survey on Drug Use and Health, an estimated 4.0 million people in the United States aged 12 or older had an opioid use disorder in the past year. OUD is associated with significant health risks, including overdose, infectious diseases, and increased rates of morbidity and mortality. About Obesity Obesity is a chronic, complex disease and a significant global public health concern. According to the World Obesity Federation, more than 1 billion people worldwide are living with obesity, while almost 3 billion are living with overweight or obesity. In the United States, approximately 40% of adults are living with obesity, according to the Centers for Disease Control and Prevention. Research has also identified addictive-like eating behaviors in some individuals with obesity, including food cravings and impaired control over eating, with behavioral and reward mechanisms that may overlap with those associated with substance use disorders The economic burden is also substantial. According to the CDC, obesity costs the U.S. healthcare system nearly $173 billion annually. The World Obesity Federation projects that the global economic impact of overweight and obesity could reach $4.32 trillion annually by 2035 - nearly 3% of global GDP - including healthcare costs and economic losses associated with reduced productivity and premature mortality. Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. BioCorRx Inc. info@BioCorRx.com 714-462-4880 Investor Relations: Crescendo Communications, LLC 212-671-1020 x304 bicx@crescendo-ir.com View the original release on www.newmediawire.com Released September 10, 2026

背景：克罗恩病（Crohn’s disease, CD）常对标准治疗难治，且患者有时不愿启动免疫抑制治疗，因此促使人们对低剂量纳曲酮（low-dose naltrexone, LDN）等新型治疗产生兴趣。目的：评估LDN对轻中度活动性CD患者诱导缓解的疗效。方法：研究人员在荷兰7家医院开展了一项多中心、双盲、安慰剂对照试验。患有活动性CD（定义为内镜下黏膜溃疡且CD简单内镜评分3–15）的成人按1:1随机分配接受LDN 4.5 mg每日一次或安慰剂治疗12周。主要终点为第12周的内镜缓解。次要终点包括临床和内镜应答、安全性及患者报告结局指标。该试验因无效而提前停止。结果：共有41例患者被随机分组。12周后，LDN组和安慰剂组分别有1例（5.6%）和3例（18.8%）达到内镜缓解（p=0.233）。临床缓解率分别为22.2%（LDN）和70.0%（安慰剂）（p=0.037）。未报告严重不良事件。在FACIT-疲劳问卷方面，12周后LDN组的中位差异为2.5（IQR 0–7），安慰剂组为?3（IQR ?7–2）（p=0.012）。此外，患者报告结局在LDN组和安慰剂组之间无显著差异。结论：LDN对诱导CD缓解无效，且未显示优于安慰剂的获益。尽管该药物对临床和内镜结局并非有效治疗，但可能通过减轻疲劳症状改善生活质量。未来研究需阐明其对炎症性肠病患者疲劳症状的潜在获益。**低剂量纳曲酮治疗克罗恩病：一项提前终止的随机试验解读**克罗恩病（Crohn’s disease, CD）是一种慢性、透壁性炎症性肠道疾病，常反复发作，累及消化道各段。尽管目前已有多种治疗药物，包括免疫抑制剂、生物制剂等，但临床上仍有大量患者对标准治疗反应不佳或不能耐受，同时部分患者对启动免疫抑制治疗存在顾虑。此外，常用免疫抑制和生物制剂也存在感染、恶性肿瘤及全身性副作用等安全性问题。因此，临床上对安全、耐受性好的新型治疗存在显著未满足需求。低剂量纳曲酮（low-dose naltrexone, LDN）是阿片受体拮抗剂纳曲酮在小剂量（如4.5 mg）下的应用，既往小样本研究和开放性试验曾报告其对CD有良好疗效，缓解率可高达88%，并显示出内镜改善。然而，这些研究多缺乏严格的内镜终点和对照设计。为客观评估LDN在CD中的疗效，研究人员开展了一项多中心、随机、双盲、安慰剂对照试验。研究人员在荷兰7家医院纳入了经内镜确认存在活动性黏膜病变的轻中度CD成人患者，共随机分配41例患者接受LDN 4.5 mg每日一次或安慰剂治疗12周。主要终点为第12周的内镜缓解，定义为SES-CD≤2且所有检查肠段的溃疡面亚评分≤1。次要终点包括内镜应答、临床缓解（Harvey–Bradshaw指数[HBI]≤4且未使用糖皮质激素）、临床应答、炎症生物标志物变化及患者报告结局。试验在纳入41例患者后因无效提前终止，最终分析样本量小于计划量。**主要研究方法与技术**本研究为多中心、双盲、安慰剂对照的随机临床试验（randomized controlled trial, RCT），在荷兰7家医院开展。患者筛选采用回结肠镜检查确认活动性病灶，并以简单内镜评分（SES-CD）量化疾病活动度。随机化按中心分层，由协调中心研究药房采用计算机生成方案分配。研究药物为纳曲酮4.5 mg口服胶囊，每日一次，安慰剂为外观相同的惰性胶囊。主要疗效分析基于可用病例数据，内镜评分由对治疗分组设盲的经验丰富的内镜医师完成。患者报告结局通过多个标准化问卷采集，包括短炎症性肠病问卷（SIBDQ）、患者报告结局-2（PRO2）、五水平欧洲五维健康量表（EQ-5D-5L）、工作生产力和活动受损问卷（WPAI）、慢性病治疗功能评估-疲劳量表（FACIT-F）以及患者报告结局测量信息系统（PROMIS）中的焦虑、抑郁和睡眠障碍模块。实验室检测包括C反应蛋白（CRP）和粪便钙卫蛋白（FP）。**研究结果****患者分布与基线特征**：2021年1月至2023年6月共纳入44例患者，其中41例在基线时随机分组（安慰剂组21例，LDN组20例），34例（83%）完成12周试验并接受随访结肠镜。基线特征在两组间均衡，平均年龄45岁，男性占26%；中位SES-CD为4，中位HBI为6，符合轻中度活动性CD。约16%患者同时使用稳定剂量的CD伴随药物。**内镜结局**：第12周时，LDN组的内镜缓解率（1/18，5.6%）低于安慰剂组（3/16，18.8%），差异无统计学意义（p=0.233）。内镜应答（SES-CD较基线降低≥50%）在LDN组为11.1%（2/18），安慰剂组为18.8%（3/16），差异亦不显著（p=0.530）。两组中位SES-CD从基线至12周均保持为4，无内镜改善证据。**临床结局**：临床缓解（HBI≤4）在安慰剂组为70.0%（7/10），显著高于LDN组的22.2%（2/9），p=0.037，是唯一有显著差异的疗效终点且有利于安慰剂。临床应答（HBI下降≥3分）在安慰剂组为40%，LDN组为20%，无显著差异（p=0.232）。HBI中位变化在安慰剂组为?2，LDN组为?1，差异无统计学意义（p=0.683）。该结果提示LDN未改善CD的临床症状。**生物标志物与患者报告结局**：第12周时，两组CRP和粪便钙卫蛋白水平变化无显著差异。生活质量评分（SIBDQ、EQ-5D-5L、PRO2）在两组间均无显著差异。焦虑、抑郁和睡眠障碍问卷评分同样无组间差异。然而，FACIT-F疲劳评分显示LDN组较安慰剂组有显著改善（中位差异2.5 vs ?3，p=0.012），提示LDN可能减轻疲劳症状。另有一个工作生产力受损评分（WPAI_CD）显著有利于安慰剂组（p=0.008），但该结果需结合次要结局的多次比较谨慎解读。**安全性与耐受性**：12周研究期间未报告严重不良事件。LDN组报告不良事件的患者数（12例）多于安慰剂组（6例），大多轻微且自限。常见副作用包括睡眠障碍（LDN组5例，安慰剂组2例）、一过性头痛（LDN组5例）等。实验室检查未发现与LDN相关的肝毒性或显著异常。**讨论与结论**：本研究是一项提前终止的随机安慰剂对照试验，结果显示LDN 4.5 mg每日一次连续12周，在轻中度CD患者中未带来临床或内镜获益。与既往开放性研究和小样本试验不同，本研究中LDN未改善SES-CD或HBI。这种差异可能源于研究设计、患者选择、安慰剂效应或发表偏倚。既往早期报告常缺乏内镜终点，且患者群体高度选择。尽管LDN的免疫调节机制在体外和动物模型中已有证实，但这些效应可能未转化为中重度活动性CD的临床获益。值得注意的是，LDN组疲劳评分有显著改善，6分的改善幅度超过了最小临床重要差异（3–4分），提示其可能在减轻疲劳方面具有潜在价值。但疲劳为次要终点，且分析限于小样本亚组，该结果应视为探索性和假设生成性质。安全性方面，LDN总体耐受性良好，未观察到严重毒性，但睡眠障碍和头痛等轻微不良事件在LDN组更常见。本研究的优势包括客观内镜终点、多中心、安慰剂对照设计。主要局限性为样本量小和提前终止导致检验效能不足。此外，允许稳定伴随治疗可能混杂疗效评估；安慰剂组临床缓解率异常高，可能与纳入患者基线疾病活动较轻或安慰剂效应有关。研究未采用CDAI作为临床终点，也未检测血清内啡肽水平以确认LDN的靶点参与。总体而言，提前终止的试验数据不支持LDN在轻中度CD中诱导缓解的临床有意义获益，因此不支持在轻中度CD中常规使用LDN。虽然LDN对临床和内镜结局无效，但可能通过减轻疲劳改善生活质量。未来研究应聚焦于探讨LDN在炎症性肠病患者疲劳症状方面的潜在作用及机制。