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Efficacy that supports up to 2 months of long-lasting stability1,2*

The efficacy of ABILIFY ASIMTUFII® (aripiprazole) is based on pivotal studies of ABILIFY MAINTENA® (aripiprazole).1

* Stability is defined as delayed time to recurrence of clinical worsening, psychiatric hospitalization, or increased risk of suicide.3

52-Week Maintenance Study 12-Week Acute Study Non-Pivotal Data

ABILIFY MAINTENA significantly delayed time to relapse† vs placebo in adults living with schizophrenia over 52 weeks (HR=0.199; 95% CI 0.1–0.3; P<0.0001)3,4

Primary endpoint: Time from randomization to relapse† vs placebo3

Proportion of patients with relapse at 52 weeks, Graph
Proportion of patients with relapse at 52 weeks, Graph

This figure is based on a total of 80 relapse events.4

80 REDUCED RISK OF RELAPSE†
vs placebo (HR=0.199; 95% CI 0.1 – 0.3; P<0.0001)4

The HR was used to calculate the reduction in risk of relapse for patients on ABILIFY MAINTENA vs placebo.4

Study design summary: Pivotal 52-week, randomized, double-blind, placebo-controlled, maintenance study in adults living with schizophrenia (N=403). The study followed a 4-phase design: conversion to and stabilization on oral aripiprazole (phases 1–2), followed by conversion to and stabilization on ABILIFY MAINTENA 400 mg (phase 3), before entering the double-blind phase (phase 4).3

† Relapse was defined as one or more of the following: clinical worsening, psychiatric hospitalization, risk of suicide, or violent behavior.3

CI=confidence interval; HR=hazard ratio IM=intramuscular.

The pivotal 52-week, randomized, double-blind, placebo-controlled, maintenance study in adults living with schizophrenia evaluated time to relapse* with ABILIFY MAINTENA vs placebo:3

The maintenance study consisted of four phases. The study enrolled patients living with schizophrenia diagnosed ≥3 years and a history of symptom exacerbation or relapse* when not receiving antipsychotic treatment.3

* Relapse was defined as one or more of the following: clinical worsening, psychiatric hospitalization, risk of suicide, or violent behavior.3 † Patients continued oral aripiprazole 10–20mg in the first 14 days following the initial ABILIFY dose.2 ‡ Patients were randomized at baseline to receive either ABILIFY MAINTENA or placebo.3 

IM=intramuscular.

Relapse was defined as one, or more, of the following:3

Clinical worsening

  • CGI-improvement score ≥5 and an increase on any of the four specific PANSS* items to a score of >4: with an absolute increase of ≥2 on that specific item since randomization OR
  • With an absolute increase of ≥4 on the combined score of these items since randomization

Risk of suicide

  • CGI-Severity of Suicidality score of:
    • 4 (very suicidal) or
    • 5 (attempted suicide) on part 1 OR
  • CGI-Severity of Suicidality score of:
    • 6 (much worse) or
    • 7 (very much worse) on part 2

Psychiatric hospitalization

  • Due to worsening of psychotic symptoms

Violent behavior

  • Clinically significant self-injury, injury to another person, or property damage

* PANSS items were conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content.3

CGI=Clinical Global Impression; PANSS=Positive and Negative Syndrome Scale.

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Are your patients ready for up to 2 months of long-lasting stability?1,2‡

‡ Stability is defined as delayed time to recurrence of clinical worsening, psychiatric hospitalization, or increased risk of suicide;3 or delayed time to relapse, defined as one or more of the following: clinical worsening, psychiatric hospitalizations, risk of suicide, or violent behavior.5

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See Our Patient Profiles

ABILIFY MAINTENA significantly improved symptoms vs placebo for adults with schizophrenia from baseline to Week 10 (treatment difference: -15.1 [95% CI -19.4 to -10.8])6

Primary endpoint: Mean change in PANSS total score§ from baseline to Week 10 with ABILIFY MAINTENA vs placebo6

LSM reduction from BL in PANSS total score at 12 weeks, Graph
LSM reduction from BL in PANSS total score at 12 weeks, Graph

Study design summary: Pivotal 12-week randomized, double-blind, placebo-controlled study in acutely relapsed adults§ living with schizophrenia. Patients were randomized to receive ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172). Safety was assessed throughout the duration of the study.6

§ Baseline characteristics: PANSS total score ≥80 and specific psychotic symptoms on the PANSS with a score >4 on each of the four specific items (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content).6

BL=baseline; CI=confidence interval; LSM=least square means; PANSS=Positive and Negative Syndrome Scale.

The pivotal 12-week, randomized, double-blind, placebo-controlled study in acutely relapsed adults* living with schizophrenia evaluated change in PANSS total score from baseline to Week 10 with ABILIFY MAINTENA vs placebo.6

Acutely relapsed adults* living with schizophrenia were randomized to receive ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172), with 14 days of oral aripiprazole or oral placebo after the first injection based on treatment arm. Safety was assessed throughout the duration of the study.6

* Baseline characteristics: PANSS total score ≥80 and specific psychotic symptoms on the PANSS with a score >4 on each of the four specific items (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content).6 † Percentages provided were patient-reported estimations. All patients underwent a seven-day washout period at trial entry.7

PANSS=Positive and Negative Syndrome Scale.

PRELAPSE study: A non-pivotal investigator-initiated study of ABILIFY MAINTENA in clinical settings

The Prevention of Relapse in Schizophrenia (PRELAPSE) study was an investigator-initiated, multicenter, cluster-randomized clinical trial funded by Lundbeck and Otsuka America Pharmaceutical, Inc. The study analyzed the time to first psychiatric hospitalization over 2 years in patients treated with ABILIFY MAINTENA vs clinician’s choice.8

While the funders participated in the study design, they had no influence on the trial's conduct, data collection, analysis, manuscript writing, or decision to submit for publication.8

Study design: Non-pivotal, 2-year, cluster-randomized, open-label, investigator-initiated study in adults with early-phase schizophrenia at 39 U.S. community treatment centers. Safety and hospitalizations were assessed throughout the study.8

Primary endpoint: Time to first psychiatric hospitalization with ABILIFY MAINTENA vs clinicians’s choice over 2 years8

Survival probability at 720 days, Graph
Survival probability at 720 days, Graph

22.2% of ABILIFY MAINTENA patients met criteria for first hospitalizations vs 36.0% of clinician’s choice patients.8

Clinicians’ choice was defined as treatment as usual, such as medication, including possible oral or LAI antipsychotics, and other available services.8

The HR was used to calculate the reduction in risk of first hospitalization for patients on ABILIFY MAINTENA vs placebo.8

Study limitations:8

  • Only one study medication (ABILIFY MAINTENA)
  • Clinicians at ABILIFY MAINTENA sites offered ABILIFY MAINTENA without charge to patients in addition to other available services
  • Clinician’s choice sites allowed the use of LAIs, and sites were required to have clinical support; therefore, clinician’s choice sites had higher use of LAIs at baseline and during the study than US statistics would suggest
  • 51% of patients (n=130) at clinician’s choice sites received an LAI at some point during the study

CI=confidence interval; HR=hazard ratio; LAI=Long-acting injectable.

The PRELAPSE study was an investigator-initiated, multicenter, cluster-randomized clinical trial that randomized 41 sites in the US to receive either ABILIFY MAINTENA or clinician’s choice.8

¶ LAIs included ABILIFY MAINTENA (15.4%) or another LAI (15.4%) at time of consent;8 # 1 site was withdrawn from each arm due to 0 recruited patients for a total of 39 sites analyzed;8 || LAIs included ABILIFY MAINTENA (3.9%) and another LAI (23.5%) at the time of consent.8 

LAI=long-acting injectable.

Inclusion criteria8
Schizophrenia diagnosis confirmed by the Structured Clinical Interview for DSM-5, Research Version (SCID-5)
<5 years of lifetime antipsychotic use
Age of 18 to 35 years
Ability to provide informed consent
Exclusion criteria8
Primary DSM-5 diagnosis other than schizophrenia
Pregnant or lactating women
Unstable medical condition
Prior clozapine use
History of intolerance to aripiprazole (ABILIFY MAINTENA sites only)

DSM-5= Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; SCID-5=Structured Clinical Interview for DSM-5.

Medications allowed at clinician's choice sites per protocol included8,9**

Oral antipsychotics
Included but not limited to:
  • Aripiprazole
  • Lurasidone HCI
  • Olanzapine
  • Quetiapine fumarate
  • Risperidone
  • Ziprasidone
LAI antipsychotics††
Included but not limited to:
  • Aripiprazole
  • Fluphenazine decanoate
  • Haloperidol decanoate
  • Olanzapine
  • Paliperidone palmitate
  • Risperidone

** The percentage of patients on each of the different medications was not reported.9 †† Administered via IM injection.9

HCl=hydrochloride; IM=intramuscular.

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ABILIFY MAINTENA and ABILIFY ASIMTUFII offer one or two months of sustained
plasma concentrations per dose, respectively.1,2‡‡

Learn More About the Pharmacokinetic Data
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ABILIFY ASIMTUFII, which is given once every two months, uses the same molecule as ABILIFY MAINTENA... the difference is that ABILIFY ASIMTUFII works over a longer time frame.— Gustavo Alva, MD, DFAPA 

Discover What Your Peers Are Saying
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Proven safety for your adult patients.1,2§§

Explore the Safety Data

Speakers are paid by Otsuka and Lundbeck and the opinions expressed are their own.
‡‡ Based on a 32-week pharmacokinetic study of ABILIFY MAINTENA and ABILIFY ASIMTUFII in adult patients with schizophrenia and bipolar I disorder.10 §§ Based on a 12-week study of ABILIFY MAINTENA vs placebo in patients living with schizophrenia.1

 

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY ASIMTUFII® (aripiprazole) and ABILIFY MAINTENA® (aripiprazole)

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.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including aripiprazole. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of aripiprazole, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. Prescribing should be consistent with the need to minimize TD. If antipsychotic treatment is withdrawn, TD may remit, partially or completely.

Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking aripiprazole. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping aripiprazole if such urges develop.

Orthostatic Hypotension or Syncope: ABILIFY ASIMTUFII and ABILIFY MAINTENA may cause orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension. Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ABILIFY ASIMTUFII or ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: ABILIFY ASIMTUFII and ABILIFY MAINTENA should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ABILIFY ASIMTUFII and ABILIFY MAINTENA may impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that therapy with ABILIFY ASIMTUFII or ABILIFY MAINTENA does not affect them adversely.

Body Temperature Regulation: Use ABILIFY ASIMTUFII or ABILIFY MAINTENA with caution in patients who may experience conditions that increase body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with aripiprazole. Use caution in patients at risk for aspiration.

Alcohol: Advise patients to avoid alcohol while taking ABILIFY ASIMTUFII or ABILIFY MAINTENA.

Concomitant Medications: Dosage reductions are recommended in patients who are CYP2D6 poor metabolizers and/or in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days. Avoid concomitant use of CYP3A4 inducers with ABILIFY ASIMTUFII and ABILIFY MAINTENA for greater than 14 days. Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.

Most Commonly Observed Adverse Reactions: The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence of ≥5% and at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation.

Injection Site Reactions:

  • ABILIFY MAINTENA: In a short-term, clinical trial with ABILIFY MAINTENA in patients with schizophrenia treated with gluteally administered ABILIFY MAINTENA, the percent of patients reporting any injection site-related adverse reaction was 5.4% and 0.6% for placebo. In an open-label study of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed at approximately equal rates.
  • ABILIFY ASIMTUFII: In an open-label study in patients with schizophrenia or bipolar I disorder, the percent of patients reporting any injection site-related adverse reactions was 19% for ABILIFY ASIMTUFII and 9.0% for ABILIFY MAINTENA. In both treatment groups, the majority of the injection site pain events coincided with the first injection and were reported with decreasing frequency upon subsequent injections. Patient-reported rating of pain was similar in both treatment groups at the last injection.

Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy: Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including ABILIFY ASIMTUFII and ABILIFY MAINTENA, during pregnancy.

Lactation: Aripiprazole is present in human breast milk. Monitor the breastfed infant for dehydration and lack of appropriate weight gain. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ABILIFY ASIMTUFII or ABILIFY MAINTENA and any potential adverse effects on the breastfed infant from ABILIFY ASIMTUFII or ABILIFY MAINTENA or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATIONS

ABILIFY ASIMTUFII® (aripiprazole) is an atypical antipsychotic indicated for treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults.

ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY ASIMTUFII and ABILIFY MAINTENA.

References: 1. ABILIFY ASIMTUFII® (aripiprazole) Prescribing Information. 2. ABILIFY MAINTENA® (aripiprazole) Prescribing Information. 3. Kane JM, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(5):617–624. 4. Data on file. ABIMAI-027. 5. Calabrese JR, et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder: a double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry. 2017;78(3):324–331. 6. Kane JM, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;72(11):1254–1260. 7. Data on file. ABIMAI-122. 8. Kane JM, et al. Effect of long-acting injectable antipsychotics vs usual care on time to first hospitalization in early-phase schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(12):1217–1224. 9. Kane. Collaborative Clinical Protocol. JAMA Psychiatry. 2020. 10. Harlin M, et al. A randomized, open-label, multiple-dose, parallel-arm, pivotal study to evaluate the safety, tolerability, and pharmacokinetics of aripiprazole 2-month long-acting injectable in adults with schizophrenia or bipolar I disorder. CNS Drugs. 2023;37:337–350.