CLINICAL TRIALS PROFILE FOR ABILIFY MAINTENA KIT

All Clinical Trials for Abilify Maintena Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02146547 ↗	European Long-acting Antipsychotics in Schizophrenia Trial	Completed	UMC Utrecht	Phase 4	2015-02-01	Schizophrenia is a chronic psychiatric illness with periods of remission and relapse. Patients vary in the frequency and severity of relapse, time until relapse and time in remission. Discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication. However, despite its apparent "common sense" this approach has neither been universally accepted by practicing psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we aim to investigate possible advantages of depot medication over oral antipsychotics in an independently designed and conducted, randomized, pragmatic trial.
NCT02472652 ↗	Aripiprazole, Abilify Maintena Collaborative Clinical Protocol	Terminated	Otsuka America Pharmaceutical	Phase 4	2015-06-01	Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men and women. Antipsychotic induced sexual side effects may be a barrier to treatment compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have higher rates of causing prolactin elevations that may be implicated in sexual dysfunction. The basic premise of this study is to identify patients who believe they have experienced sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels. Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine if such a switch is helpful.
NCT02472652 ↗	Aripiprazole, Abilify Maintena Collaborative Clinical Protocol	Terminated	Gazda, Thomas D., M.D., PC	Phase 4	2015-06-01	Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men and women. Antipsychotic induced sexual side effects may be a barrier to treatment compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have higher rates of causing prolactin elevations that may be implicated in sexual dysfunction. The basic premise of this study is to identify patients who believe they have experienced sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels. Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine if such a switch is helpful.
NCT02717130 ↗	Aripiprazole, Abilify Maintena Collaborative Clinical Protocol	Terminated	Burrell Behavioral Health	N/A	2016-06-08	An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180- day Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective Re-hospitalization Rates while on Oral Antipsychotic Medication.

Clinical Trial Conditions for Abilify Maintena Kit

Condition Name

Condition Name for Abilify Maintena Kit
Intervention	Trials
Schizophrenia	7
Sexual Dysfunction	1
Antipsychotics	1
Aripiprazole	1

Condition MeSH

Condition MeSH for Abilify Maintena Kit
Intervention	Trials
Schizophrenia	7
Disease	1
Bipolar Disorder	1

Clinical Trial Locations for Abilify Maintena Kit

Trials by Country

Trials by Country for Abilify Maintena Kit
Location	Trials
United States	7
Korea, Republic of	7
Spain	4
Germany	4
Italy	3

Trials by US State

Trials by US State for Abilify Maintena Kit
Location	Trials
Ohio	1
Texas	1
California	1
Arkansas	1
Missouri	1

Clinical Trial Progress for Abilify Maintena Kit

Clinical Trial Phase

Clinical Trial Phase for Abilify Maintena Kit
Clinical Trial Phase	Trials
Phase 4	5
Phase 1	3
N/A	1

Clinical Trial Status

Clinical Trial Status for Abilify Maintena Kit
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Active, not recruiting	1

Clinical Trial Sponsors for Abilify Maintena Kit

Sponsor Name

Sponsor Name for Abilify Maintena Kit
Sponsor	Trials
Otsuka Pharmaceutical Development & Commercialization, Inc.	2
Otsuka Beijing Research Institute	2
Burrell Behavioral Health	1

Sponsor Type

Sponsor Type for Abilify Maintena Kit
Sponsor	Trials
Other	9
Industry	8

Abilify Maintena: Clinical Trials, Market Analysis, and Projections

Introduction

Abilify Maintena, developed by Otsuka Holdings, is a long-acting injectable (LAI) formulation of the atypical antipsychotic aripiprazole. It is used for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar I disorder. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Schizophrenia Trials

Abilify Maintena has been extensively evaluated in clinical trials for its efficacy and safety in treating schizophrenia. A pivotal 52-week, placebo-controlled, double-blind, randomized-withdrawal Phase 3 maintenance trial demonstrated that Abilify Maintena significantly delayed the time to relapse compared to placebo. The trial involved 269 adult patients receiving Abilify Maintena and 134 patients receiving placebo, with a hazard ratio of 5.03 (95% CI = 3.15-8.02, p < 0.0001)[4].

Bipolar I Disorder Trials

In addition to schizophrenia, Abilify Maintena has been approved for the treatment of bipolar I disorder. Clinical trials have shown its efficacy in maintaining stability and preventing relapse in patients with bipolar I disorder. For instance, a 52-week open-label study in patients with bipolar I disorder reported shifts from normal to high fasting cholesterol in 2.1% of patients, highlighting the need for monitoring metabolic parameters[1].

Safety Profile

The safety profile of Abilify Maintena has been assessed in multiple studies. Common adverse reactions include injection site reactions, weight gain, and changes in lipid profiles. For example, a 12-week double-blind placebo-controlled study in adults with schizophrenia showed that patients treated with Abilify Maintena experienced shifts in total cholesterol, fasting triglycerides, LDL cholesterol, and HDL cholesterol, although these changes were generally not clinically significant[1].

Market Analysis

Current Market Position

Abilify Maintena has been a blockbuster drug since its approval in 2013, driven by its efficacy and the convenience of its once-monthly dosing. It has become one of the leading LAI antipsychotics by sales, with forecast sales of $1.5 billion in 2024. The drug's popularity stems from its ability to provide consistent medication delivery and improve patient adherence[2].

Market Exclusivity and Generic Competition

However, the market landscape for Abilify Maintena is set to change significantly. The drug is approaching the loss of market exclusivity in both Europe and the US in October 2024. This will lead to the introduction of generic versions, which is expected to mark the beginning of a decline in Abilify Maintena’s sales. According to GlobalData, a 12% decline in Otsuka’s sales is expected from 2024 to 2025, with a projected compound annual growth rate (CAGR) of -21% from 2024 to 2029[2].

Projections and Future Outlook

Sales Decline

The impending introduction of generics is expected to significantly impact Abilify Maintena’s sales. By the end of 2029, sales are projected to plummet from $1.5 billion in 2024 to just $459 million. This steep decline underscores the challenges Otsuka will face in maintaining market share in the post-exclusivity period[2].

Market Impact

While the loss of exclusivity will negatively impact Otsuka’s sales, it is expected to have a positive outcome for the wider market. The increased competition and lower prices due to generic entries will make the drug more accessible to a larger patient population. This shift can enhance the overall treatment landscape for schizophrenia and bipolar I disorder by increasing the availability of affordable antipsychotic medications[2].

Global Market Share

Despite the anticipated decline, Otsuka aims to maintain a significant market presence. The company has targeted achieving a 30% global market share for Abilify Maintena, although this goal may be challenging in the face of generic competition. The global market for atypical antipsychotic LAIs continues to grow, driven by the need for better medication adherence in schizophrenia and bipolar disorder[5].

Key Takeaways

• Clinical Efficacy: Abilify Maintena has demonstrated significant efficacy in delaying relapse in patients with schizophrenia and bipolar I disorder.
• Safety Profile: The drug has a manageable safety profile, although it requires monitoring for metabolic changes and injection site reactions.
• Market Position: Abilify Maintena is a leading LAI antipsychotic, but its sales are expected to decline with the loss of market exclusivity.
• Generic Competition: The introduction of generics in 2024 will significantly impact sales, with a projected decline from $1.5 billion to $459 million by 2029.
• Market Accessibility: The increased competition will make the drug more accessible to patients, enhancing the overall treatment landscape.

FAQs

What is Abilify Maintena used for?

Abilify Maintena is used for the maintenance treatment of schizophrenia in adults and for the treatment of acute manic and mixed episodes associated with bipolar I disorder[3].

How is Abilify Maintena administered?

Abilify Maintena is administered via a once-monthly intramuscular injection, often accompanied by an initial two weeks of oral aripiprazole[4].

What are the common adverse reactions associated with Abilify Maintena?

Common adverse reactions include injection site reactions, weight gain, and changes in lipid profiles such as shifts in total cholesterol, fasting triglycerides, LDL cholesterol, and HDL cholesterol[1].

What is the impact of generic competition on Abilify Maintena’s sales?

The introduction of generics in 2024 is expected to lead to a significant decline in Abilify Maintena’s sales, with a projected CAGR of -21% from 2024 to 2029[2].

How does the loss of market exclusivity affect patient access to Abilify Maintena?

The loss of market exclusivity and the introduction of generics will make the drug more accessible to a larger patient population due to increased competition and lower prices[2].

Sources

1. FDA Label: Abilify Asimtufii - accessdata.fda.gov
2. Pharmaceutical Technology: Otsuka's Abilify Maintena: dual drug expiry signals sales decline
3. European Medicines Agency: ABILIFY MAINTENA, aripiprazole - European Medicines Agency
4. Otsuka: FDA Approves Once-Monthly ABILIFY MAINTENA™ (Aripiprazole) For Extended-Release Injectable Suspension for the Treatment of Schizophrenia
5. Otsuka: Five-Year Growth Phase (2019–2023) - otsuka.com