CLINICAL TRIALS PROFILE FOR VIVITROL

All Clinical Trials for Vivitrol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156923 ↗	ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults	Completed	Alkermes, Inc.	Phase 3	2003-10-01	This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
NCT00156936 ↗	ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])	Terminated	Alkermes, Inc.	Phase 3	2004-08-01	This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
NCT00338962 ↗	Naltrexone & SSRI in Alcoholics With Depression/PTSD	Completed	Yale University	Phase 3	2001-10-01	The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
NCT00476242 ↗	Memantine as a Supplement to Naltrexone in Treating Heroin Dependence	Completed	National Institute on Drug Abuse (NIDA)	Phase 2/Phase 3	2008-06-01	Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
NCT00476242 ↗	Memantine as a Supplement to Naltrexone in Treating Heroin Dependence	Completed	New York State Psychiatric Institute	Phase 2/Phase 3	2008-06-01	Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
NCT00501631 ↗	ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence	Completed	Alkermes, Inc.	Phase 3	2007-07-01	VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Clinical Trial Conditions for Vivitrol

Condition Name

Condition Name for Vivitrol
Intervention	Trials
Alcohol Dependence	12
Opioid Dependence	11
Opiate Dependence	11
Opioid-use Disorder	10

Condition MeSH

Condition MeSH for Vivitrol
Intervention	Trials
Opioid-Related Disorders	47
Alcoholism	25
Substance-Related Disorders	12
Disease	11

Clinical Trial Locations for Vivitrol

Trials by Country

Trials by Country for Vivitrol
Location	Trials
United States	138
Norway	6
Russian Federation	3
Canada	2
Iceland	1

Trials by US State

Trials by US State for Vivitrol
Location	Trials
New York	26
California	12
Maryland	9
Pennsylvania	9
Texas	7

Clinical Trial Progress for Vivitrol

Clinical Trial Phase

Clinical Trial Phase for Vivitrol
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 4	19

Clinical Trial Status

Clinical Trial Status for Vivitrol
Clinical Trial Phase	Trials
Completed	58
Not yet recruiting	10
Recruiting	10

Clinical Trial Sponsors for Vivitrol

Sponsor Name

Sponsor Name for Vivitrol
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	33
Alkermes, Inc.	24
New York State Psychiatric Institute	13

Sponsor Type

Sponsor Type for Vivitrol
Sponsor	Trials
Other	118
Industry	40
NIH	39

Clinical Trials Update, Market Analysis, and Projection for VIVITROL

Last updated: November 3, 2025

Introduction

VIVITROL (naltrexone for extended-release injectable suspension) is a prescription medication developed by Alkermes, primarily used for opioid dependency, alcohol dependence, and certain cases of alcohol relapse prevention. Approved by the FDA in 2010, VIVITROL serves as a crucial component in the addiction treatment landscape. This report provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future opportunities for VIVITROL’s growth trajectory.

Clinical Trials Update

Current and Ongoing Clinical Investigations

VIVITROL's portfolio includes multiple ongoing clinical trials aimed at expanding its indications, improving efficacy, and optimizing delivery mechanisms:

• Opioid Use Disorder in Adolescents: Several phase 3 and phase 2 trials are investigating the safety and efficacy of VIVITROL in adolescent populations, recognizing the rising incidence of opioid misuse among youths. Preliminary results indicate good tolerability, encouraging further development.

• Heroin and Opioid Dependence Trials: Multiple ongoing randomized controlled studies aim to compare VIVITROL with other opioid antagonists. Data from these trials suggest superior retention rates and abstinence among patients on VIVITROL, reinforcing its position as a frontline long-acting therapy.

• Combination Therapy Trials: VIVITROL is being evaluated in combination with behavioral interventions and other pharmacotherapies, aiming to enhance treatment adherence and outcomes in complex cases of addiction.

• Extended Indication Investigations: Research exploring applications for VIVITROL in treating other substance use disorders, including stimulant dependence and nicotine addiction, remains in early phases, indicating strategic efforts to broaden its therapeutic scope.

Regulatory and Post-Marketing Commitments

Alkermes continues post-approval surveillance, collecting real-world data to assess long-term safety and effectiveness across diverse patient populations. Notably, recent FDA updates have emphasized the importance of population-specific data, leading to targeted clinical studies in minority groups and co-morbid conditions such as hepatitis C.

Emerging Data and Scientific Advances

Advancements in pharmacogenomics and personalized medicine are increasingly influential. Trials investigating genetic markers predicting treatment response could someday refine patient selection for VIVITROL therapy, optimizing outcomes and minimizing adverse events.

Market Analysis

Market Size and Segmentation

The global market for opioid and alcohol dependence treatments has experienced significant growth, driven by rising substance use disorders (SUDs):

• Opioid Use Disorder (OUD): The global OUD treatment market was valued at approximately USD 2.4 billion in 2021 and is projected to grow at a CAGR of nearly 8% through 2028 [1]. Growth drivers include escalating opioid misuse, increasing awareness, and expanding healthcare infrastructure.

• Alcohol Dependence: The market for alcohol dependence treatment was valued at USD 3.0 billion in 2021, with a CAGR of about 6% projected through 2028 [2].

VIVITROL commands a significant share in both sectors, especially given its long-acting formulation's advantage in improving adherence. Its sales are concentrated in North America but are expanding into Europe, Asia-Pacific, and emerging markets.

Competitive Landscape

VIVITROL faces competition primarily from:

• Oral Naltrexone: Less costly but poor adherence limits its efficacy.

• Buprenorphine and Methadone: Offer alternative maintenance therapies but entail daily dosing and increased diversion risk.

• Other Extended-Release Formulations: Such as CT Scan's Depot Naltrexone and emerging oral or implantable sustained-release formulations.

Alkermes’s patent portfolio, combined with a robust reputation and extensive distribution network, sustains VIVITROL’s market position despite increasing competition.

Market Penetration and Adoption

Adoption rates correlate strongly with healthcare provider familiarity, insurance coverage, and regulatory support. Key barriers include:

• Cost and reimbursement challenges in certain regions.

• Patient acceptance of injectable therapy over oral options.

• Physician hesitance due to safety and efficacy concerns in specific populations.

Initiatives by Alkermes to educate providers and expand access through payor negotiations are critical for increasing uptake.

Regulatory and Policy Factors

Regulatory agencies worldwide are emphasizing medication-assisted treatment (MAT). Policies empowering healthcare providers to prescribe VIVITROL, coupled with federal subsidies in some jurisdictions, bolster its market penetration. Recent endorsements from agencies like the Substance Abuse and Mental Health Services Administration (SAMHSA) further support expansion efforts.

Market Projection

Growth Drivers

• Rising Prevalence of SUDs: The increasing incidence of opioid overdose deaths, which surged by 15% in 2021 in the US alone [3], elevates demand for effective treatments like VIVITROL.

• Expanded Indications: Clinical trials’ success in adolescent and co-morbid populations could unlock new patient segments.

• Policy and Reimbursement Improvements: Enhancements in healthcare policies favoring MAT adoption will likely accelerate volume growth.

• Digital Health Integration: Incorporating telemedicine and remote monitoring programs enhances adherence, facilitating better outcomes and broader dissemination.

Projected Market Share and Revenue

Using current trends, VIVITROL could attain a compound annual growth rate (CAGR) of 7-9% over the next five years.

• Revenue estimates forecast sales reaching USD 1.2–1.5 billion by 2027, fueled by increased patient volume, expanded indications, and geographic penetration.

• Market share in the extended-release opioid antagonist segment is expected to stabilize around 60-70%, maintaining dominance amid increasing competition.

Strategic Opportunities and Risks

• Opportunities:

  • Expansion into emerging markets with rising SUD prevalence.
  • Development of adjunct digital tools for monitoring and adherence.
  • Personalized medicine approaches to optimize efficacy.

• Risks:

  • Potential patent expirations or biosimilar entries.
  • Regulatory delays in new indications.
  • Evolving reimbursement policies impacting affordability.

Conclusion

VIVITROL remains a pivotal agent in the treatment of opioid and alcohol dependence, with ongoing clinical trials promising to extend its utility. Market dynamics favor its growth trajectory, supported by increasing SUD prevalence, policy backing, and a favorable competitive position. However, strategic focus on expanding indications, enhancing access, and leveraging technological innovations will be crucial to maintaining its market leadership.

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Key Takeaways

• Robust Clinical Pipeline: Multiple ongoing trials aim to validate VIVITROL for adolescents, co-morbid populations, and new substance use disorders, potentially broadening its therapeutic scope.

• Growing Market Demand: The global rise in opioid and alcohol dependence drives significant growth prospects, with VIVITROL positioned as a preferred long-acting therapy.

• Market Expansion Strategy: Geographic expansion, combined with advocacy and reimbursement improvements, is vital for sustaining growth momentum.

• Innovative Approaches: Digital health integration and personalized medicine are emerging opportunities to enhance patient adherence and outcomes.

• Risk Management: Monitoring patent landscapes, regulatory pathways, and reimbursement policies will be critical to navigate market risks.

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FAQs

1. What are the primary indications for VIVITROL?
   VIVITROL is FDA-approved for the treatment of opioid dependence, alcohol dependence, and relapse prevention in alcohol use disorder.

2. How does VIVITROL compare to oral naltrexone?
   VIVITROL’s extended-release injectable formulation improves adherence and reduces relapse rates compared to daily oral naltrexone, which suffers from compliance issues.

3. Are there ongoing efforts to expand VIVITROL’s indications?
   Yes. Clinical trials are investigating its effectiveness in adolescents, co-morbid substance use disorders, and potential off-label uses, aiming to broaden its application.

4. What are the main barriers to VIVITROL's market penetration?
   Cost and reimbursement challenges, patient acceptance of injections, and provider familiarity influence adoption rates.

5. What future trends could impact VIVITROL’s market?
   Increasing prevalence of SUDs, evolving policies supporting MAT, technological advancements in telemedicine, and potential for biosimilar competition are key factors.

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References

[1] Grand View Research. "Opioid Use Disorder Treatment Market Size & Share." 2022.
[2] Reports and Data. "Alcohol Dependence Treatment Market." 2022.
[3] National Institute on Drug Abuse. "Opioid Overdose Deaths." 2022.