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.

Clinical Trial Conditions for Vivitrol

Condition Name

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

Condition MeSH

Condition MeSH for Vivitrol
Intervention	Trials
Opioid-Related Disorders	45
Alcoholism	24
Substance-Related Disorders	12
Disease	11

Clinical Trial Locations for Vivitrol

Trials by Country

Trials by Country for Vivitrol
Location	Trials
United States	128
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	11
Maryland	9
Pennsylvania	9
Connecticut	7

Clinical Trial Progress for Vivitrol

Clinical Trial Phase

Clinical Trial Phase for Vivitrol
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	22
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Vivitrol
Clinical Trial Phase	Trials
Completed	58
Not yet recruiting	10
Recruiting	9

Clinical Trial Sponsors for Vivitrol

Sponsor Name

Sponsor Name for Vivitrol
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	30
Alkermes, Inc.	24
New York State Psychiatric Institute	13

Sponsor Type

Sponsor Type for Vivitrol
Sponsor	Trials
Other	117
Industry	39
NIH	36

Vivitrol: Clinical Trials, Market Analysis, and Projections

Introduction

Vivitrol, an extended-release injectable suspension of naltrexone, is a crucial medication in the treatment of opioid and alcohol dependence. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Vivitrol Pilot Study in Los Angeles County

A pilot study conducted in Los Angeles County evaluated the feasibility and effectiveness of Vivitrol in substance use disorder treatment programs. The study found that Vivitrol significantly increased the number of clients who completed treatment in detoxification, outpatient counseling, and residential treatment programs. It also decreased substance use among clients and increased treatment engagement and continuance, particularly in residential settings[1].

Rapid Initiation of Injection Naltrexone

The SWIFT trial, conducted by the NIDA Clinical Trials Network, tested the rapid initiation procedure for extended-release naltrexone (XR-naltrexone) compared to standard procedures. The trial showed that rapid initiation could make XR-naltrexone a more viable treatment option for patients with opioid use disorder (OUD), improving the rate of initiation and potentially reducing opioid withdrawal severity and craving[4].

Market Analysis

Current Market Position

Vivitrol is Alkermes’s highest-grossing drug, with projected sales of up to $410 million in 2023. The drug has been a significant player in the opioid and alcohol dependence treatment market since its FDA approval in 2006 for alcohol dependence and in 2010 for opioid dependence[2][5].

Competitive Landscape

The opioid addiction market is dominated by opioid agonist therapies such as methadone and buprenorphine, which are widely available in generic forms. However, Vivitrol, as a branded product, maintains a strong market presence due to its unique formulation and efficacy. The upcoming launch of generic versions of Vivitrol by Teva in 2027 is expected to introduce competition, but Alkermes has secured patent protection until then[2][3][5].

Market Projections

The opioid addiction market, which includes Vivitrol, is valued at $2 billion in 2023 and is expected to grow at a CAGR of more than 1% from 2023 to 2033. New pipeline agents, such as Cannabidiol and Mazindol CR, are anticipated to drive market growth, although generic versions of existing treatments may impact the market share of branded products like Vivitrol[3].

Patent and Generic Versions

Patent Settlement with Teva

Alkermes has settled a patent infringement lawsuit with Teva, allowing Teva to market a generic version of Vivitrol starting January 15, 2027, or earlier under certain conditions. This settlement is two years ahead of the 2029 patent expiration for Vivitrol[2][5].

Market Dynamics and Challenges

Market Size and Growth

The opioid addiction market is characterized by a slow growth rate, primarily due to the dominance of cheap generic opioid agonist therapies. However, the introduction of new treatments and the continued need for effective opioid and alcohol dependence treatments will drive the market forward[3].

Regulatory and Legal Challenges

Alkermes has faced regulatory scrutiny, including a warning letter from the FDA for omitting safety risks in one of its ads. Additionally, the company has been under investigation for its marketing practices, which could impact public perception and regulatory oversight[5].

Key Takeaways

• Clinical Efficacy: Vivitrol has shown significant efficacy in increasing treatment completion and reducing substance use in clinical trials.
• Market Position: Vivitrol remains a high-grossing drug for Alkermes, despite the upcoming competition from generic versions.
• Market Growth: The opioid addiction market is expected to grow slowly, driven by new pipeline agents and continued demand for effective treatments.
• Patent Protection: Alkermes has secured patent protection for Vivitrol until January 2027, after which generic versions will be introduced.

FAQs

What is Vivitrol and how does it work?

Vivitrol is an extended-release injectable suspension of naltrexone, used to treat opioid and alcohol dependence by blocking opioid receptors in the brain.

What were the findings of the Vivitrol pilot study in Los Angeles County?

The pilot study found that Vivitrol increased treatment completion, decreased substance use, and improved treatment engagement and continuance among clients.

When will generic versions of Vivitrol be available?

Generic versions of Vivitrol will be available starting January 15, 2027, following a patent settlement between Alkermes and Teva.

How does Vivitrol compare to other opioid addiction treatments?

Vivitrol is a branded product that competes with generic opioid agonist therapies like methadone and buprenorphine, offering a unique formulation and efficacy profile.

What are the projected sales for Vivitrol in 2023?

Vivitrol is projected to generate up to $410 million in sales in 2023.

What regulatory challenges has Alkermes faced with Vivitrol?

Alkermes has faced a warning letter from the FDA for omitting safety risks in one of its ads and has been under investigation for its marketing practices.

Sources

1. Vivitrol Evaluation Pilot Results - University of California, Los Angeles Integrated Substance Abuse Programs Department of Public Health.
2. Alkermes fends off generic versions of Vivitrol until 2027 - Pharmaceutical Technology.
3. Opioid Addiction Market Opportunity Assessment and Forecast to 2033 - GlobalData.
4. Rapid Initiation of Injection Naltrexone for Opioid Use Disorder - JAMA Network Open.
5. Alkermes grants Teva license to launch generic Vivitrol in 2027 - FiercePharma.