NDAINTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASEPriority Review
Approved
Apr 2006
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
40
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIVITROL (naltrexone) is an extended-release intramuscular suspension formulation of naltrexone, a pure opioid receptor antagonist approved in 2006. It is indicated for treatment of alcohol dependence and for blockade of exogenously administered opioids. The drug works by competitively binding to opioid receptors, preventing the subjective effects of opioids and reducing alcohol consumption through modulation of the endogenous opioid system. VIVITROL is positioned as a long-acting maintenance therapy option in the addiction treatment landscape.
$0.1BPart D
3.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (40)
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
Started Apr 2026
33 enrolled
Opioid Use Disorder
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
Started Jul 2025
150 enrolled
Alcohol AddictionAlcoholism
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Started Jun 2025
108 enrolled
Obesity; DrugObesity, Morbid
Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial
Started Jan 2025
0Migraine
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
Started Jan 2024
8,600 enrolled
Obesity
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.