This post was sponsored by Otsuka and Lundbeck.

ABILIFY ASIMTUFII® (aripiprazole) for the Maintenance Treatment of Bipolar I Disorder

SUPPORTED BY

GUSTAVO ALVA

MD, DFAPA

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INDICATIONS

ABILIFY ASIMTUFII® (aripiprazole) is an atypical antipsychotic indicated for:

  • Treatment of schizophrenia in adults
  • Maintenance monotherapy treatment of bipolar I disorder in adults

ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for:

  • Treatment of schizophrenia in adults
  • Maintenance monotherapy treatment of bipolar I disorder in adults

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY ASIMTUFII and ABILIFY MAINTENA are not approved for the treatment of patients with dementia-related psychosis.


Dr. Gustavo Alva is the Medical Director of ATP Clinical Research and a practicing psychiatrist at Pacific Neuropsychiatric Specialists in Costa Mesa, California. He is engaged academically as an Assistant Professor at the University of California, Riverside School of Medicine and a Visiting Professor in the Psychiatry International Program at UAG School of Medicine in Guadalajara, Mexico.

For patients living with bipolar I disorder, maintaining stability is crucial. I’d like to explore how ABILIFY ASIMTUFII, the only once every 2-month long-acting injectable (LAI) for the maintenance treatment of bipolar I disorder, can help patients with long-term management of their bipolar I disorder.

Let’s review the efficacy and safety data of ABILIFY ASIMTUFII to give you a better idea of how to discuss this valuable treatment option with your patients.

What Sets ABILIFY ASIMTUFII Apart?

ABILIFY ASIMTUFII is unique as it is the only FDA-approved LAI that is administered once every 2 months for the maintenance monotherapy treatment of bipolar I disorder, using the same active molecule as ABILIFY MAINTENA® (aripiprazole), but with a longer duration of action.1

Pharmacokinetic Bridging Study and Efficacy Insights

A 32-week open-label, pharmacokinetic bridging study that established the similarity of aripiprazole plasma concentrations between ABILIFY ASIMTUFII and ABILIFY MAINTENA in adult patients living with schizophrenia or bipolar I disorder has shown that ABILIFY ASIMTUFII 960 mg maintains comparable plasma concentrations to ABILIFY MAINTENA 400 mg, providing consistent efficacy over 2 months.1 This finding supports the use of ABILIFY ASIMTUFII in providing sustained symptom control with six doses per year.

The efficacy of ABILIFY ASIMTUFII is based on the adequate and well-controlled study of ABILIFY MAINTENA for the treatment of bipolar I disorder in adults. Let’s review the data from a pivotal 52-week double-blind, placebo-controlled, randomized withdrawal study of ABILIFY MAINTENA.2

Phase 1 of the study involved switching patients from other antipsychotics to oral aripiprazole. In Phase 2, those patients who successfully switched to oral aripiprazole, along with patients already on this treatment for bipolar I disorder, were stabilized on a daily dose of 15 to 30 mg. Phase 3 involved a single-blind segment of at least 12 weeks and began with an initial dose of ABILIFY MAINTENA 400 mg while continuing daily oral aripiprazole for 2 more weeks. Finally, Phase 4 was a double-blind, placebo-controlled segment that lasted up to 52 weeks, where participants either continued ABILIFY MAINTENA or switched to a placebo via intramuscular depot.2

The primary endpoint was time from randomization to recurrence of any mood episode. In this study, recurrence was defined as one or more of the following: clinical worsening, psychiatric hospitalization, or increased risk of suicide.2

Results from this pivotal study showed that patients who were treated with ABILIFY MAINTENA remained free of any mood episodes significantly longer than those on placebo. More specifically, ABILIFY MAINTENA significantly delayed the time to recurrence of any mood episode with a P-value of less than 0.0001 and a hazard ratio, or HR, of 0.45.2

An analysis of an exploratory endpoint evaluated in the ABILIFY MAINTENA bipolar I disorder maintenance study found that ABILIFY MAINTENA significantly delayed time to recurrence for a manic episode (HR=0.259 [95% confidence interval, or CI, 0.136-0.495]) or mixed episode (HR=0.202 [95% CI, 0.044-0.939]) with no substantial difference in the time to a depressive episode (HR=0.932 [95% CI, 0.497-1.747]).3 Patients on ABILIFY MAINTENA experienced a 75% reduced risk of recurrence of mixed-/manic-mood episodes vs placebo (HR=0.249 [95% CI, 0.137-0.451]).3

Safety Data

Safety is a paramount consideration in any treatment modality. The safety of ABILIFY ASIMTUFII is based on an adequate and well-controlled 12-week study of ABILIFY MAINTENA in patients living with schizophrenia. In this study, the most observed adverse reactions associated with ABILIFY MAINTENA were increased weight, akathisia, injection site pain, and sedation. These most commonly observed adverse reactions occurred in at least 5% of patients and at a rate at least twice that of placebo. Importantly, no patients on ABILIFY MAINTENA or placebo discontinued due to these four adverse reactions.4

The percentage of patients in the open-label study reporting any injection site-related adverse reactions (all reported as injection site pain) was 19% for patients treated with ABILIFY ASIMTUFII 960 mg and 9% for patients treated with ABILIFY MAINTENA 400 mg.1

Please note, ABILIFY ASIMTUFII and ABILIFY MAINTENA have a BOXED WARNING: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY ASIMTUFII and ABILIFY MAINTENA are not approved for the treatment of patients with dementia-related psychosis.

Administration of ABILIFY ASIMTUFII

If tolerability to aripiprazole has been established, the initial dose of ABILIFY ASIMTUFII 960 mg can be given. However, the patient must continue taking their oral aripiprazole or current oral antipsychotic for the next 14 days. After that, they don’t take any more medication until their next injection is due, 56 days after the first one. Patients may be given their injection up to 2 weeks before or 2 weeks after the scheduled timepoint.

ABILIFY ASIMTUFII can be initiated from any oral antipsychotic. However, if the patient has never taken aripiprazole, the first step is to establish tolerability to oral aripiprazole, which may take up to 2 weeks due to its half-life. Then, the initial dose of ABILIFY ASIMTUFII can be administered. Additionally, the patient should continue their current oral antipsychotic for 14 consecutive days.

For patients transitioning from ABILIFY MAINTENA, the switch can be made directly at the next scheduled dose without requiring re-establishment of tolerability, facilitating seamless continuity of care.

A benefit of ABILIFY ASIMTUFII is its dosing flexibility—although maintaining a scheduled dosing regimen is recommended, if a patient misses an injection, they have up to 6 weeks from their scheduled dose in which they can receive the next injection without having to restart oral overlap.

Please see the FULL PRESCRIBING INFORMATION for details about ABILIFY ASIMTUFII dosage adjustments and CYP450 considerations in dosing.

Concluding Thoughts

ABILIFY ASIMTUFII represents another treatment option in the management of bipolar I disorder. Its once every 2-month dosing not only simplifies the treatment regimen, but also ensures consistent drug delivery,1 which is ideal for maintaining stability in bipolar disorder. As clinicians, we aim to offer treatments that control symptoms effectively and align with our patients’ lifestyles.

ABILIFY ASIMTUFII offers a potential option to many patients struggling with the challenges of bipolar I disorder. It is imperative that we remain committed to patient-centered care, ensuring that each person receives the most appropriate and effective treatment for them.