Vivitrol (naltrexone extended-release injectable suspension) / Alkermes - LARVOL DELTA

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: BioCorRx Pharmaceuticals Inc

New P1 trial

Self-Reported Cognitive Impairments in Office-Based Treatment for Opioid Use Disorder with Buprenorphine or Extended-Release Naltrexone. (PubMed, Subst Use) - "All scales were associated with a range of demographic and clinical variables. Most adults receiving office-based MAT for OUD reported self-perceived cognitive impairment, but neurological comorbidities may also play a role in these perceptions."

Journal • Addiction (Opioid and Alcohol) • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Epilepsy • Psychiatry • Substance Abuse

Lived Experiences of Medication for Opioid Use Disorder: Clients' Perspectives on Formulation and Treatment. (PubMed, Subst Use) - "This study aimed to explore clients' perceptions and experiences of using oral Suboxone and injectable Vivitrol for OUD treatment. Our study provides valuable insights drawn from clients' experiences using oral and injectable MOUD in substance use treatment facilities. The findings will be useful for healthcare providers and policymakers to consider the pros and cons of these medications in substance use treatment settings."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Letter: Safety and Tolerability of Injectable Extended-Release Naltrexone for the Management of Alcohol Use Disorder in Advanced Alcohol-Associated Liver Disease-Authors' Reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fibrosis • Hepatology • Immunology • Psychiatry

Influenza A-Induced Acute Liver Injury: A Rare Adverse Effect (ACG 2025) - "The patient's home medications include atorvastatin, carbamazepine, cyclobenzaprine, famotidine, fluoxetine, gabapentin, hydroxyzine, metformin, multivitamin, propranolol, senna, Seroquel, vitamin B1, Vivitrol. Additionally, labs from a month ago showed liver enzymes to be at baseline. These findings along with the IVA infection point towards IAV-induced ALF.Given the potential for ALI, especially in severely ill patients, routine liver enzyme testing is recommended in the management of IAV infection."

Adverse events • Autoimmune Hepatitis • Chronic Kidney Disease • Hepatology • Immunology • Infectious Disease • Inflammation • Influenza • Liver Failure • Metabolic Disorders • Respiratory Diseases

NALTREXONE-ASSOCIATED EOSINOPHILIC PNEUMONIA: WHEN THE CURE BECOMES A PULMONARY CHALLENGE (CHEST 2025) - "A modest troponin rise (0.01 to 0.05 ng/mL) suggested demand ischemia, but normal BNP, absence of edema, and a normal echocardiogram ruled out heart failure.Empiric treatment with azithromycin and ceftriaxone was initiated for presumed pneumonia, and diuretics were administered for pulmonary edema...Extensive infectious and autoimmune testing was negative, supporting a diagnosis of acute eosinophilic pneumonia likely secondary to Vivitrol.The patient received systemic corticosteroids—six days of prednisone followed by two days of IV solumedrol (60 mg TID then BID)—then transitioned to oral prednisone 50 mg with a taper... This case underscores a rare adverse reaction to Vivitrol resulting in acute eosinophilic pneumonia. Although corticosteroid treatment provided initial respiratory improvement, long-term outcomes were compromised by recurrent alcohol use disorder and social instability. Clinicians should remain vigilant for drug-induced hypersensitivity in patients with..."

Addiction (Opioid and Alcohol) • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Congestive Heart Failure • Eosinophilia • Epilepsy • Heart Failure • Immunology • Infectious Disease • Pneumonia • Pulmonary Embolism • Respiratory Diseases

Long-acting naltrexone restores network connectivity in subjects with co-morbid cannabis and opioid use disorder. (PubMed, bioRxiv) - "All participants underwent imaging prior to receiving a therapeutic dose of long-acting intramuscular NTX (Vivitrol ® ), an approved treatment for OUD and AUD but not for CocUD, and again two weeks post-administration. In contrast, little change in FC was observed in co-morbid CocUD. These findings, combined with prior evidence that NTX reduces cannabis use by dampening the experience of reward, suggest NTX may hold promise as a treatment for CanUD."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

HSC-MS-24-0024: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: The University of Texas Health Science Center, Houston | N=20 ➔ 2 | Trial completion date: Jan 2026 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Dec 2024; Unable to recruit eligible participants and expiration of study medication.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia • Tobacco Cessation

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects. (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Inventage Lab., Inc. | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Multiple Sclerosis

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2 | N=1516 | Active, not recruiting | Sponsor: NYU Langone Health | N=2190 ➔ 1516

Enrollment change • Substance Abuse

BIOPIN 101b: A Phase 1b Study Comparing the Pharmacokinetics and Safety of Low- and High-Dose BIOPIN Naltrexone Implants With Monthly Vivitrol Injections in Healthy Volunteers Over 12 Months (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Drug Delivery Company, LLC DBA Akyso Pharmaceuticals

New P1 trial • Substance Abuse

Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: University of Pennsylvania | N=200 ➔ 3 | Trial completion date: Jan 2027 ➔ Aug 2024 | Not yet recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Aug 2024; Primary funding source has ended.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Addiction (Opioid and Alcohol) • Substance Abuse

Safety and Tolerability of Injectable Extended-Release Naltrexone for the Management of Alcohol Use Disorder in Advanced Alcohol-Associated Liver Disease. (PubMed, Aliment Pharmacol Ther) - "In this case series, XR-NTX was well tolerated in patients with advanced ALD, without evidence of hepatotoxicity or liver decompensation."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fatigue • Fibrosis • Hepatology • Immunology • Liver Failure • Pain • Psychiatry

HSC-MS-24-0024: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: The University of Texas Health Science Center, Houston | Trial completion date: Apr 2025 ➔ Jan 2026 | Trial primary completion date: Feb 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia • Tobacco Cessation

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2 | N=2190 | Active, not recruiting | Sponsor: NYU Langone Health | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2 | N=2190 | Recruiting | Sponsor: NYU Langone Health | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial primary completion date • Substance Abuse

Treatment patterns and healthcare resource use among veterans initiating medication for incident moderate-to-severe alcohol use disorder. (PubMed, Am J Addict) - "This real-world study is among the first to describe clinical characteristics, treatment patterns, and HCRU in VHA patients who initiated MAUDs when all MAUDs were included in the VHA formulary."

Journal • Addiction (Opioid and Alcohol)

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (clinicaltrials.gov) - P4 | N=675 | Completed | Sponsor: NYU Langone Health | Recruiting ➔ Completed

Trial completion • Substance Abuse

Naltrexone in AUD Reward Drinkers (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Nov 2026 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: University of Pennsylvania | N=60 ➔ 3 | Trial completion date: Jul 2028 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2028 ➔ Aug 2024; Primary funding source has ended.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Substance Abuse

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "'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...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...ARISTADA: Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023...VIVITROL: Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023."

Commercial • New P2 trial • P2 data • Bipolar Disorder • CNS Disorders • Narcolepsy • Schizophrenia • Sleep Disorder

Vivitrol Treatment for Cannabis Use Disorder (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Centre for Addiction and Mental Health | N=10 ➔ 1 | Unknown status ➔ Terminated; Funder contract terminated

Enrollment change • Trial termination • Substance Abuse

Social Network Barriers to Extended-Release Naltrexone Within Rural Appalachia: Perspectives from Justice-Involved Clients and Clinicians. (PubMed, Subst Use Misuse) - "Extended-release naltrexone (XR-NTX, Vivitrol®) is an effective, but underutilized, evidence-based treatment for people with opioid use disorder (POUD) who are incarcerated...In concordance with clinicians, POUDs received high levels of emotional support, but lacked instrumental, financial, and treatment support from networks. The network characteristics of Appalachian POUDs recently released from prison create challenges associated with recovery, which may be addressed through network and educational interventions."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

GASTROINTESTINAL AND LIVER ADVERSE EFFECTS OF MEDICAL TREATMENTS OF ALCOHOL USE DISORDER: A PHARMACOVIGILANCE ANALYSIS OF THE FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) DATABASE (AASLD 2024) - "The drugs identified were disulfiram, acamprosate, oral naltrexone, and intramuscular naltrexone (Vivitrol). Naltrexone had overall better gastrointestinal and liver safety profile compared to disulfiram and acamprosate, with intramuscular naltrexone showing lower side effects than oral naltrexone. Disulfiram has the highest risk of liver toxicity followed by acamprosate."

Adverse events • Addiction (Opioid and Alcohol) • Gastrointestinal Disorder • Hepatology • Liver Failure • Pain

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects. (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Inventage Lab., Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)