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Last update 25 Mar 2025

Naltrexone

Last update 25 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryNaltrexone, an opioid antagonist, has been utilized for treating addiction to both drugs and alcohol. VIVITROL, a medication containing naltrexone, is approved for patients with alcohol dependence who can abstain from alcohol before medication initiation. At the initial administration of VIVITROL, patients must not be actively drinking. Following opioid detoxification, VIVITROL can also be utilized to prevent relapse to opioid dependence. It is vital to keep in mind that VIVITROL should be incorporated into a comprehensive management program that includes psychosocial support. Naltrexone works by blocking opioid receptors, specifically the mu/kappa/delta receptors, thus preventing the effects of opioids. Unlike buprenorphine and methadone that activate opioid receptors to suppress cravings, naltrexone binds and blocks opioid receptors, reducing opioid cravings. Moreover, it does not cause withdrawal symptoms upon discontinuation and does not possess abuse and diversion potential.

Drug Type

Small molecule drug

Synonyms

DBR-LDN, Naltrexone implant, naltrexone implant(Drug Delivery Company)

+ [11]

Target

Opioid receptors x μ opioid receptor

Action

antagonists

Mechanism

Opioid receptors antagonists(Opioid receptors antagonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Other DiseasesDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication

Opium DependenceAlcoholismMethamphetamine abuse+ [11]

Inactive Indication

Acquired Immunodeficiency SyndromeAcral Lentiginous Malignant MelanomaAlcohol-Related Disorders+ [24]

Originator Organization

Alkermes, Inc.

Active Organization

Neurelis, Inc.

Scilex Pharmaceuticals, Inc.Indivior PLC

+ [8]

Inactive Organization

National Cancer Institute

National Institute on Alcohol Abuse & AlcoholismHershey Medical Center

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (13 Apr 2006),

Alcoholism

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC20H23NO4

InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N

CAS Registry16590-41-3

244

Clinical Trials associated with Naltrexone

NCT06845124

/ Not yet recruitingPhase 2IIT

ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence

Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.

Start Date01 Jul 2025

Sponsor / Collaborator

Zentralinstitut für Seelische Gesundheit

[+2]

NCT06633900

/ Not yet recruitingPhase 2/3IIT

Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV

The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are:
What are the challenges for implementing naltrexone as an overdose prevention strategy?
Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants?
How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids?
Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other.
Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

Start Date15 Feb 2025

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT06723561

/ Not yet recruitingPhase 2IIT

Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury.
Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools
There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial.
Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

Start Date01 Jan 2025

Sponsor / Collaborator

Medical College of Wisconsin

100 Clinical Results associated with Naltrexone

100 Translational Medicine associated with Naltrexone

100 Patents (Medical) associated with Naltrexone

9,820

Literatures (Medical) associated with Naltrexone

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

Author: Sheng, Nan ; Wu, Jianbing ; Fang, Fang ; Duan, Zhimin ; Xu, Beilei ; Li, Chengrang ; Song, Hao ; Zheng, Junyou

BACKGROUND:

Hailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.

OBJECTIVE:

To confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.

METHODS:

Two patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.

RESULTS:

Two patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.

CONCLUSION:

Naltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

01 May 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

LC-MS/MS method for the simultaneous quantification of thiafentanil and naltrexone in bovine muscle, liver and kidney

Article

Author: Kellermann, Tracy ; Laurence, Michael ; Bruce, Mieghan ; Christie, Judith T ; Pfitzer, Silke ; Raath, Jacobus P ; Laubscher, Liesel

Thiafentanil is a µ-opioid agonist used for the chemical immobilisation of a variety of ungulate species and is antagonised by the administration of naltrexone. The potential for these ungulates to be hunted for consumption by humans or predators raises concerns of drug residues in animal tissues. No analytical method to quantify tissue residue concentrations of thiafentanil has been previously reported. This research developed an LC-MS/MS method to quantify thiafentanil in bovine muscle, and both thiafentanil and naltrexone in bovine liver and kidney matrices. The analytical method was applied to quantify tissue residues in samples collected from goats 1, 2, 3, and 6 days post thiafentanil administration. The assay was validated over the calibration range 6.25-200 ng/mg for thiafentanil in muscle, and 3.13-400 ng/mg for thiafentanil and 57.8-7400 ng/mg for naltrexone in liver and kidney. No residues above the lowest limit of quantification were detected in the injection site, longissimus dorsi muscle, liver or kidney samples collected from the goats. The reported analytical method and residue depletion data provide a foundation for future thiafentanil and naltrexone residue depletion studies in wildlife species.

01 May 2025·Contemporary Clinical Trials

Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals

Article

Author: Digranes, Linn Camilla Wergeland ; Holtan, Line ; Kunoe, Nikolaj ; Tanum, Lars ; Benth, Jūratė Šaltytė ; Solli, Kristin Klemmetsby

BACKGROUND:

Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.

OBJECTIVES:

This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids.

METHODS:

After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.

RESULTS:

The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (p < 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (p < 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p < 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (n = 35) during the study.

CONCLUSION:

Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.

CLINICALTRIALS:

gov no. NCT01717963.

244

News (Medical) associated with Naltrexone

11 Mar 2025

·www.prnewswire.com

Currax Pharmaceuticals: Peer-Reviewed Study in Obesity Pillars Further Substantiates Cardiovascular Safety Profile of CONTRAVE®/MYSIMBA®

BRENTWOOD, Tenn., March 11, 2025 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax"), a specialty pharmaceutical company and manufacturer of the #1 branded oral weight loss medication CONTRAVE® (naltrexone HCl/bupropion HCl), today announced the publication of its Cardiovascular Health Outcomes Analysis (HOA) for CONTRAVE®/MYSIMBA® in Obesity Pillars, the official journal of the Obesity Medicine Association. This peer-reviewed study, based on electronic health record data from more than 24,600 patients followed for over 4.7 years, found no evidence of excess cardiovascular risk and no statistically significant difference in major adverse cardiovascular events (MACE) between CONTRAVE/MYSIMBA and the comparator drug. The study's publication provides important real-world evidence that further substantiates the cardiovascular safety profile of CONTRAVE/MYSIMBA building on findings from prior clinical trials, a systemic literature review, two published FDA Adverse Event Reporting System (FAERS) database studies, and over ten years of post-marketing safety surveillance. These results provide valuable insights to support regulatory and clinical decision-making in the treatment of obesity. "The publication of this analysis in Obesity Pillars underscores the utility of evaluating long-term cardiovascular outcomes in routine clinical practice," said Michael Kyle, M.D., SVP, Chief Medical Officer of Currax Pharmaceuticals. "The findings further substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA, aligning with previous clinical and observational studies." CONTRAVE, approved in the U.S. and marketed in Europe as MYSIMBA, has been studied extensively in both randomized clinical trials and observational settings. The latest analysis builds upon prior research, including the LIGHT trial, and complements the ongoing INFORMUS trial, a large-scale cardiovascular outcomes study, which now has enrolled more than 3,000 patients and is designed to meet regulatory post-marketing requirements to further characterize long-term cardiovascular safety. "Obesity is a serious chronic disease, and it's critical that healthcare professionals have access to rigorous, data-driven evidence when considering treatment options," said George Hampton, President and CEO of Currax Pharmaceuticals. "Currax continues to invest in clinical trials designed to increase the utility of Contrave for physicians treating obesity." The full study is available in Obesity Pillars: About Currax Pharmaceuticals LLC Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on tackling the #1 and #2 causes of preventable death in the United States, smoking and obesity. Currax distributes a range of both branded and generic pharmaceutical products, including CONTRAVE® (naltrexone HCl/bupropion HCl), ONZETRA® Xsail® (sumatriptan nasal powder), Silenor® (doxepin), Treximet®, (sumatriptan/naproxen sodium), and the authorized generic of Treximet®. For more information, please visit . WHAT IS CONTRAVE? Along with diet and exercise, CONTRAVE is a prescription weight-loss medicine that may help some adults with a BMI > 30 kg/m2 (obese) or with a BMI of > 27 kg/m2 (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off. It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke. It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products. CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). IMPORTANT SAFETY INFORMATION CONTRAVE can cause serious side effects including: Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment. While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes. Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping. CONTRAVE is not approved for use in children under the age of 18. Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE. Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may cause serious side effects, including: Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death. Get emergency medical help right away if you take opioids and you: have trouble breathing become very drowsy with slowed breathing have slow, shallow breathing feel faint, very dizzy, confused, or have unusual symptoms Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery. Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing. Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE. Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem. Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again. Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk. Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE. The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the Full Prescribing Information, including Medication Guide, for CONTRAVE. Media Contact [email protected] SOURCE Currax Pharmaceuticals LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical Result

10 Mar 2025

·www.biocorrx.com

BioCorRx Pharmaceuticals Inc. Announces That it has Acquired LUCEMYRA(R) (lofexidine), an FDA-Approved Opioid Withdrawal Medication, From USWM, LLC

ANAHEIM, CA and LOUISVILLE, KY - March 10, 2025 (NEWMEDIAWIRE) - BioCorRx Inc. (OTCQB: BICX) (the "Company"), a developer and provider of innovative treatment programs for substance abuse and related disorders and USWM LLC, a specialty pharmaceutical company dedicated to addressing unmet medical needs, today announced that the Company's subsidiary BioCorRx Pharmaceuticals Inc., entered into a definitive agreement to acquire LUCEMYRA (lofexidine), a U.S. Food and Drug Administration (FDA) approved prescription medication for opioid withdrawal from USWM, LLC. LUCEMYRA is the first and only non-opioid medication approved by the FDA to mitigate opioid withdrawal symptoms, providing critical relief for patients undergoing opioid detoxification. BioCorRx Pharmaceuticals Inc. projects LUCEMYRA to continue generating meaningful sales, positioning it as a key asset in BioCorRx Pharmaceutical Inc.'s expanding product line and represents its first FDA approved commercialized product. Under the general terms of the agreement, USWM, LLC will retain a portion of future sales up to a capped amount in lieu of a direct cash payment at closing, BioCorRx Pharmaceuticals will pay a low single digit royalty to USWM, LLC, and USWM, LLC will receive shares of common stock and warrants from BioCorRx Inc. Lourdes Felix, CEO, CFO, and Director of BioCorRx Inc., and President, and Chairman of BioCorRx Pharmaceuticals Inc., commented: "This acquisition represents a significant milestone as we expand our addiction treatment offerings. LUCEMYRA provides a critical solution for patients experiencing opioid withdrawal, and we are excited to integrate it into our portfolio. We believe this strategic move will drive revenue growth and reinforce our commitment to combating the opioid crisis. Acquiring LUCEMYRA aligns with our mission to deliver innovative, non-opioid treatment solutions. By leveraging our expertise in behavioral health and our strong network of treatment centers, we aim to expand LUCEMYRA's market presence and improve access to opioid withdrawal treatment for those who need it most. Additionally, we believe that this acquisition will generate positive cash flow as we further develop our product pipeline and take the necessary steps to bring BICX104 to regulatory/FDA approval." P. Breckinridge Jones, Sr., CEO of USWM LLC, stated, "We are proud of the impact LUCEMYRA has had in helping patients manage opioid withdrawal symptoms. Finding the right partner to continue its legacy was important to us, and BioCorRx's deep commitment to addiction treatment makes them an ideal fit. We look forward to working together through this transition and seeing the continued success of LUCEMYRA under BioCorRx's leadership." About BioCorRx Inc. BioCorRx Inc. (OTCQB: 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 along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also 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®. The Company also controls BioCorRx Pharmaceuticals Inc., a clinical-stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for the treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com. About USWM LLC USWM LLC is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. More information on USWM LLC can be found at www.usworldmeds.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 A 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. About Opioid Withdrawal Opioids lower norepinephrine, a brain chemical that supports vital functions like respiration and consciousness. With continued opioid use, the brain establishes a new equilibrium by increasing compensatory norepinephrine production in order to maintain normal functioning. When opioids are removed, or the dose is significantly reduced, the brain's increased norepinephrine levels are no longer offset by the presence of the opioids. This results in a norepinephrine surge that produces the acute symptoms of withdrawal. 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. 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. Important Safety Information 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 US WorldMeds 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. BioCorRx Inc. investors@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 March 10, 2025

Drug ApprovalAcquisition

12 Feb 2025

·www.prnewswire.com

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025

— Total Revenues of $1.56 Billion in 2024; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $372 Million and Diluted GAAP Earnings per Share from Continuing Operations of $2.20 for 2024 — — ALKS 2680 Phase 2 Studies in Narcolepsy Type 1 and Type 2 Ongoing With Data Expected in H2 2025 — DUBLIN, Feb. 12, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025. "2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category." "2024 was Alkermes' strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company's ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline," said Blair Jackson, Chief Operating Officer of Alkermes. "We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company's next phase of growth." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the fourth quarter were $77.0 million. Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023. During the quarter, the company recorded LYBALVI® revenue of approximately $4 million related to year-end inventory fluctuations. ARISTADAi Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023. During the quarter, the company recorded ARISTADA® revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments. VIVITROL Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023. During the quarter, the company recorded VIVITROL® revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments. Manufacturing & Royalty Revenues Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter were $36.5 million. VUMERITY® manufacturing and royalty revenues for the fourth quarter were $35.0 million. FAMPYRA® manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward. RISPERDAL CONSTA® manufacturing revenues for the fourth quarter were $14.7 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023. In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million. Financial Expectations for 2025 All line items are according to GAAP, except as otherwise noted. Notes and Explanations 1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and twelve months ended Dec. 31, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income, EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income, EBITDA and Adjusted EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income, EBITDA and Adjusted EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects, including expected drivers of growth, value creation and profitability; and the company's expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company's other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company's products or products using the company's proprietary technologies; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA TRINZA®, RISPERDAL CONSTA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; FAMPYRATM is a trademark of Merz Pharmaceuticals, LLC; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 1Phase 2

100 Deals associated with Naltrexone

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opium Dependence	United States	Alkermes, Inc.	12 Oct 2010
Alcoholism	United States	Alkermes, Inc.	13 Apr 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Opiate Overdose	Phase 3	United States	National Institute on Drug Abuse	15 Feb 2025
Methamphetamine abuse	Phase 3	United States	National Institute on Drug Abuse	01 Jul 2024
Methamphetamine dependence	Phase 3	United States	National Institute on Drug Abuse	01 Jul 2024
Fecal Incontinence	Phase 3	United States	National Institute of Diabetes & Digestive & Kidney Diseases	29 Jun 2021
Chronic pelvic pain syndrome	Phase 3	United States	Hershey Medical Center	16 Jan 2020
Endometriosis	Phase 3	United States	Hershey Medical Center	16 Jan 2020
Binge-Eating Disorder	Phase 3	United States	National Institute of Diabetes & Digestive & Kidney Diseases	07 Aug 2019
Obesity	Phase 3	United States	National Institute of Diabetes & Digestive & Kidney Diseases	07 Aug 2019
Opioid abuse	Phase 3	United States	Alkermes, Inc.	01 Apr 2016
Acquired Immunodeficiency Syndrome	Phase 3	United States	National Institute on Alcohol Abuse & Alcoholism	01 Apr 2011

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01587196 (fMRI CURE, CTgov)	Phase 2	-	72	Vivitrol	axodppaxyo = wcnmvcbnbd idxakjaefl (dfikrisevn, jrejgepypb - gapiefqdhm) View more	-	15 Oct 2024
NCT04547985 (CTgov)	Phase 4	-	9	Placebo (Placebo)	jkmexrkyie(icyxxoiodo) = deusaietzr borgojzmbd (pkcwvmrujy, 7.36) View more	-	28 Aug 2024
				Naltrexone HCl 50 MG Oral Tablet (Naltrexone)	jkmexrkyie(icyxxoiodo) = ufncjqaynv borgojzmbd (pkcwvmrujy, NA) View more
DDW2024	Not Applicable	Liver Diseases, Alcoholic	-	Naltrexone	swawzeksvn(rlikxuurfd) = gyzfhukskq fzmjguhvig (wrzbnkmetz )	-	20 May 2024
				Acamprosate	swawzeksvn(rlikxuurfd) = orcjflhckr fzmjguhvig (wrzbnkmetz )
DDW2024	Not Applicable	Liver Diseases, Alcoholic	-	Naltrexone	mbhwsqgksc(rxkvmrthjq) = the rate of AUD medication discontinuation for adverse events was similar in both groups (14% vs 12%) and none were stopped due to suspected DILI tigebwayab (fqseqifaah ) View more	-	20 May 2024
				Acamprosate
NCT02885311 (CTgov)	Phase 1/2	Alcoholism \| Alcohol-Related Disorders	27	Brief Advice (At-Risk Drinkers (AR))	fmmqpxdcvs(fgdonhcvrd) = kgzfnyusmk cjbovjkuun (zbagoxcukf, 4.1) View more	-	30 Oct 2023
				Brief Advice+Naltrexone (Problem Drinkers (PD))	fmmqpxdcvs(fgdonhcvrd) = depxxbggra cjbovjkuun (zbagoxcukf, 8.0) View more
NCT04249882 (CTgov)	Phase 2	Alcohol Use Disorder	53	Placebo (Placebo)	wdkdtijlvw(dpzchmyjvv) = yvepyeedws puqsbhksdm (vfkqypwaqn, 6.67) View more	-	14 Sep 2023
				Varenicline (Varenicline)	wdkdtijlvw(dpzchmyjvv) = txncdkaylr puqsbhksdm (vfkqypwaqn, 6.87) View more
NCT04935931 (EDIT-N2, CTgov)	Early Phase 1	Binge-Eating Disorder	13	Naltrexone	fqeqanqlxk(pqwfyopbbc) = mmeypnxsxi rjfsmjadnk (rblxkpmgex, 0.03) View more	-	21 Aug 2023
NCT04756128 (COLTREXONE, CTgov)	Phase 2	COVID-19	142	Colchicine 0.6 mg (Colchicine-Only Arm)	knsanewias = csqujwdoro szeofmnich (sbkxihvasy, jplixcreba - tyrkprdrbx) View more	-	25 Jul 2023
				Colchicine 0.6 mg+Naltrexone (Colchicine and Naltrexone ("Combined") Arm)	knsanewias = xlvjebitfu szeofmnich (sbkxihvasy, xvtvlkgpej - ktlaxzfhrm) View more
NCT04716881 (CTgov)	Phase 1	Opioid-Related Disorders	9	Naltrexone 380 MG	tuejzwtvju(ekbdinplwz) = dnbxcmobgp fgazjuwtcc (naxghfjhpi, xtccofabzg - zndjxygcbw) View more	-	09 Jun 2023
NCT03852628 (CTgov)	Phase 2	Alcoholism \| Stress Disorders, Post-Traumatic	69	2mg Buprenex+380mg Vivitrol (2mg Buprenex and 380mg Vivitrol)	botencetgc = mbocxtgaqf dkgbsxphdj (duckbiipel, gsxpjjpldl - qvegkvcvrt) View more	-	07 Jun 2023
				Placebo (SL pill qd, IM injection q4weeks) (Placebo)	botencetgc = jdtuviajfk dkgbsxphdj (duckbiipel, jmudstvalp - rjtfnpdray) View more

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