In a 32-week, open-label, multiple-dose, randomized, parallel-arm, pharmacokinetic bridging study

ABILIFY ASIMTUFII® (aripiprazole): TWO MONTHS of sustained therapeutic concentrations with ONE DOSE

The aripiprazole concentrations of ABILIFY ASIMTUFII were explored in a pharmacokinetic bridging study, which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients living with schizophrenia or bipolar I disorder.1

Primary objectives included1:

  • To establish the similarity of aripiprazole plasma concentrations and exposure following ABILIFY ASIMTUFII and ABILIFY MAINTENA® (aripiprazole) administration
  • To establish the safety and tolerability of multiple-dose administrations of ABILIFY ASIMTUFII

Mean plasma concentrations of ABILIFY ASIMTUFII following the fourth administration were compared to concentrations following the seventh and eighth administrations of ABILIFY MAINTENA in adult patients living with schizophrenia or bipolar I disorder.

Mean aripiprazole plasma concentrations assessed after the fourth dose of ABILIFY ASIMTUFII
vs the seventh and eighth doses of ABILIFY MAINTENA1

ABILIFY ASIMTUFII after the fourth dose (n=102)¹ABILIFY MAINTENA after the seventh and eighth doses (n=93)¹Aripiprazole plasma concentration (ng/mL)40030020010000Over this two-month dosing interval, the mean plasma concentration of ABILIFY ASIMTUFII remained between 200 ng/mL and 320 ng/mLOver this two-month dosing interval, the mean plasma concentration of ABILIFY ASIMTUFII remained between 200 ng/mL and 320 ng/mL²²2856Time (days)*
ABILIFY ASIMTUFII after the fourth dose (n=102)¹ABILIFY MAINTENA after the seventh and eighth doses (n=93)¹Aripiprazole plasma concentration (ng/mL)40030020010000Over this two-month dosing interval, the mean plasma concentration of ABILIFY ASIMTUFII remained between 200 ng/mL and 320 ng/mLOver this two-month dosing interval, the mean plasma concentration of ABILIFY ASIMTUFII remained between 200 ng/mL and 320 ng/mL²²2856Time (days)*

*Day 0 corresponds to the 24th week of the 32-week study.

ABILIFY ASIMTUFII 960 mg demonstrated comparable aripiprazole concentrations, and thus comparable efficacy, to ABILIFY MAINTENA 400 mg throughout the two-month dosing interval.1

ABILIFY MAINTENA Efficacy

IMPORTANT WARNING AND PRECAUTION REGARDING 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.

Comparable efficacy over 32 weeks

Change from baseline in PANSS (schizophrenia) and YMRS (bipolar I disorder) total scores1

Schizophrenia1

Mean PANSS total scores were comparable
for ABILIFY ASIMTUFII and ABILIFY MAINTENA groups for the duration of the 32-week trial.

ABILIFY ASIMTUFII1:

Baseline (n=92): 62.0

Week 32 (n=89): 59.4

ABILIFY MAINTENA1:

Baseline (n=93): 61.8

Week 32 (n=85): 60.1

Bipolar I Disorder1

Mean YMRS total scores were comparable
for ABILIFY ASIMTUFII and ABILIFY MAINTENA groups for the duration of the 32-week trial.

ABILIFY ASIMTUFII1:

Baseline (n=40): 6.7

Week 32 (n=39): 4.8

ABILIFY MAINTENA1:

Baseline (n=41): 9.4

Week 32 (n=40): 4.7

PANSS=Positive and Negative Syndrome Scale; YMRS=Young Mania Rating Scale.

Patients treated with ABILIFY ASIMTUFII 960 mg remained clinically stable over the 32-week study period, comparable to those treated with ABILIFY MAINTENA 400 mg.1

IMPORTANT WARNING AND PRECAUTION REGARDING 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.

The safety profile of ABILIFY ASIMTUFII was comparable to that seen with ABILIFY MAINTENA.

Safety Data

The efficacy of ABILIFY ASIMTUFII® (aripiprazole) is based on the adequate and well-controlled studies of ABILIFY MAINTENA® (aripiprazole)

Schizophrenia efficacy data

12-week study design

Primary endpoint: Mean change in PANSS total score from baseline to Week 101

A 12-week, randomized, double-blind, placebo-controlled study in which acutely relapsed adult patients* living with schizophrenia were randomized to either ABILIFY MAINTENA or intramuscular placebo.1 Safety was assessed throughout the duration of the study.

*Baseline characteristics: PANSS total score ≥80 and PANSS score >4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content).1

PANSS=Positive and Negative Syndrome Scale.

ABILIFY MAINTENA showed a statistically significant reduction in PANSS total score vs placebo as early as Week 1 through Week 121

ABILIFY MAINTENA (n=168) Placebo (n=172)Least squares mean reduction 
from baseline in PANSS total score0-5-10-15-20-25-30-350Concomitant treatment with oral aripiprazole or placebo for 14 days after first injection-11.7-26.8 Week 10 (<0.0001)P-8.9 Week 1
(<0.001)P-27.2 Week 12 (<0.0001)P-5.0-12.6Early and continued symptom reduction from week 1 to week 12124681012Weeks from randomizationNumber of patients at risk1621621441341261089999167167157140117 96 8168
ABILIFY MAINTENA (n=168) Placebo (n=172)Least squares mean reduction 
from baseline in PANSS total score0-5-10-15-20-25-30-350Concomitant treatment with oral aripiprazole or placebo for 14 days after first injection-11.7Week 10 (<0.0001)P-26.8 Week 1
(<0.001)P-8.9 Week 12 (<0.0001)P-27.2 -5.0-12.6Early and continued symptom reduction from week 1 to week 12124681012Weeks from randomizationNumber of patients at risk1621621441341261089999167167157140117968168

*Baseline characteristics: PANSS total score ≥80 and PANSS score >4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content).1

PANSS=Positive and Negative Syndrome Scale.

Study design

A 12-week, randomized, double-blind, placebo-controlled study in which acutely relapsed adult patients with schizophrenia were randomized to either ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172). After initial injection, patients received 14 days of oral aripiprazole or oral placebo based on treatment arm.1

  • Primary endpoint was mean change in PANSS total score from baseline to Week 101
  • Safety was assessed throughout the duration of the study1
Patients were receiving a range of medications prior to study enrollment2†
Risperidone 21.5%
Quetiapine 15.3%
Olanzapine 8.2%
Aripiprazole 6.5%
Another antipsychotic 22.0%
No antipsychotic 26.5%

†Percentages provided were patient-reported estimations. All patients underwent a seven-day washout period at trial entry.

Screening phase

93.5% of patients were treated with an antipsychotic other than aripiprazole or no antipsychotic prior to study entry2

Patients without prior exposure received oral aripiprazole to establish tolerability.1

Patients had a mean PANSS total score of 103 (range 82 to 144) and a CGI-S score of 5.2 (markedly ill) at baseline.

CGI-S=Clinical Global Impressions-Severity of Illness.

IMPORTANT WARNING AND PRECAUTION REGARDING 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.

52-week maintenance study

Study design

In a 52-week, multiphase maintenance study of adult patients living with schizophrenia diagnosed ≥3 years with a history of symptom exacerbation or relapse when not receiving antipsychotic treatment.‡ Phases consisted of an open-label phase 1 (conversion to oral aripiprazole), an open-label phase 2 (stabilization on oral aripiprazole 10 mg to 30 mg once daily), a single-blind phase 3 (conversion and stabilization on ABILIFY MAINTENA 400 mg; patients continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA dose), and a double-blind, placebo-controlled, randomized phase 4 in which patients received either ABILIFY MAINTENA (n=269) or placebo IM depot (n=134).3

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

‡DSM-IV-TR criteria.

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

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

CI=confidence interval; DSM-IV-TR=Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; HR=hazard ratio; IM=intramuscular.

ABILIFY MAINTENA (n=269) significantly delayed time to relapse§ vs placebo (n=134) in a 52-week study (HR=0.199 [95% CI, 0.1-0.3], P<0.0001)3,4||

Primary endpoint: 
Time from randomization to relapse

ABILIFY MAINTENA (n=269) Placebo (n=134)Proportion of patients with relapse0.80.60.40.20.00481216202428323640444852Weeks from randomization⁴reduced risk of relapse vs placebo80%Number of patients at risk26924420118615313010476635444363023134118856853453727221412953
ABILIFY MAINTENA (n=269) Placebo (n=134)Proportion of patients with relapse0.80.60.40.20.00481216202428323640444852Weeks from randomization⁴reduced risk of relapse vs placebo80%Number of patients at risk26924420118615313010476635444363023134118856853453727221412953

‡DSM-IV-TR criteria.

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

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

CI=confidence interval; DSM-IV-TR=Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; HR=hazard ratio; IM=intramuscular.

The placebo-controlled, 52-week maintenance study evaluated the time
 to relapse for adult patients with schizophrenia

Study design

A multiphase study that included open-label stabilization on oral aripiprazole, single-blind stabilization on ABILIFY MAINTENA (along with oral aripiprazole for the first 14 days), and a 52-week, randomized, double-blind, placebo-controlled study in which adult patients with schizophrenia were randomized to either ABILIFY MAINTENA (n=269) or intramuscular placebo (n=134).3

The study enrolled patients with schizophrenia diagnosed ≥3 years and a history of symptom exacerbation
or relapse when not receiving antipsychotic treatment.3¶

OPEN-LABEL
PHASE 1

4-6 weeks

CONVERSION TO
ORAL ARIPIPRAZOLE
n=633
OPEN-LABEL
PHASE 2

2-8 weeks

STABILIZATION ON
ORAL ARIPIPRAZOLE
15 mg to 30 mg
once daily
n=710
SINGLE-BLIND
PHASE 3

12-36 weeks

CONVERSION AND STABILIZATION ON
ABILIFY MAINTENA® (aripiprazole)
400 mg
n=576

Patients continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA dose.

DOUBLE-BLIND,
PLACEBO-CONTROLLED, RANDOMIZED
PHASE 4

Up to 52 weeks

ABILIFY MAINTENA
n=269
OR
Placebo IM Depot
n=134

Patients were randomized at baseline to receive either ABILIFY MAINTENA or placebo.

Primary endpoint: Time from randomization to relapse3

Relapse was defined as one or more of the following3:

  • Clinical worsening
    • CGI-Improvement score ≥5 and an increase on any of the 4 specific PANSS# items to a score >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
  • Psychiatric hospitalization
    • Due to worsening of psychotic symptoms
  • Risk of suicide
    • CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on part 1 or CGI-SS score of 6 (much worse) or 7 (very much worse) on part 2
  • Violent behavior
    • Clinically significant self-injury, injury to another person, or property damage

DSM-IV-TR criteria. 

#PANSS items were conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content.3
CGI=Clinical Global Impression; CGI-SS=Clinical Global Impression of Severity of Suicidality.

IMPORTANT WARNING AND PRECAUTION REGARDING 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.

Bipolar I disorder efficacy data

52-week study design

In a 52-week multiphase maintenance study of adult patients living with bipolar I disorder with a history of ≥1 manic or mixed episode with manic symptoms that required hospitalization and/or treatment with either a mood stabilizer and/or antipsychotic (N=266).5

The placebo-controlled, 52-week maintenance study evaluated the time to recurrence for adult patients living with bipolar I disorder.5

Maintenance study of adult patients living with bipolar I disorder consisted of four phases.5

OPEN-LABEL
PHASE 1

4-6 weeks

CONVERSION TO
ORAL ARIPIPRAZOLE
n=466
OPEN-LABEL
PHASE 2

2-8 weeks

STABILIZATION ON
ORAL ARIPIPRAZOLE 15 mg to 30 mg
once daily
n=632**
SINGLE-BLIND
PHASE 3

12-28 weeks

CONVERSION AND
STABILIZATION ON
ABILIFY MAINTENA® (aripiprazole)
400 mg
n=425

Patients continued on oral aripiprazole 10 mg to 20 mg
for the first 14 days following
the initial
ABILIFY MAINTENA dose.

DOUBLE-BLIND,
PLACEBO-CONTROLLED, RANDOMIZED
PHASE 4

Up to 52 weeks

ABILIFY MAINTENA
n=133
OR
Placebo IM Depot
n=133

Patients were randomized at baseline to receive either ABILIFY MAINTENA or placebo.

**Including those patients entering the trial on oral aripiprazole.
IM=intramuscular.

Recurrence was defined as one or more of the following5:

Clinical worsening

  • YMRS total score ≥15
    OR
  • MÅDRS total score ≥15
    OR
  • CGI-BP-S overall score >4
    OR
  • Serious AE of worsening BP-I
    OR
  • Discontinuation due to lack of efficacy or due to an AE of worsening BP-I
    OR
  • Clinical worsening with the need for addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, and/or increase greater than the allowed benzodiazepine doses for treatment of symptoms of an underlying mood disorder

Psychiatric hospitalization

  • For any mood episode

Increased risk of suicide

  • Score ≥4 on the MÅDRS item 10
    OR
  • Answer of YES on question 4 or 5 on the C-SSRS

AE=adverse event; BP-I=bipolar I disorder; CGI-BP-S=Clinical Global
Impression-Bipolar Version-Severity; C-SSRS=Columbia-Suicide Severity Rating Scale; MÅDRS=Montgomery-Åsberg Depression Rating Scale; YMRS=Young Mania Rating Scale.

ABILIFY MAINTENA significantly delayed time to recurrence†† of any mood episode vs placebo over one year (HR=0.45 [95% CI, 0.30-0.68], P<0.0001)5‡‡

Significantly delayed time to recurrence for a manic episode (52 episodes; P<0.0001) and mixed episodes (11 episodes; P=0.06). No substantial difference in the time to a depressive episode (39 episodes; P=0.864).6

††Recurrence was defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide.5

‡‡This figure is based on a total of 103 recurrences.
CI=confidence interval; HR=hazard ratio.

ABILIFY MAINTENA significantly delayed time to recurrence†† of any mood episode vs placebo over one year (HR=0.45 [95% CI, 0.30-0.68], P<0.0001)5‡‡

Primary endpoint: Time from randomization to recurrence††
of any mood episode5

ABILIFY MAINTENA (n=132) Placebo (n=133)Proportion of patients with recurrence0.60.40.20.00481216202428323640444852Weeks from randomizationNumber of patients at risk132125111101938584807672706967621331211049184756759555350484337
ABILIFY MAINTENA (n=132) Placebo (n=133)Proportion of patients with recurrence0.60.40.20.00481216202428323640444852Weeks from randomizationNumber of patients at risk132125111101938584807672706967621331211049184756759555350484337

IMPORTANT WARNING AND PRECAUTION REGARDING 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.

ABILIFY MAINTENA significantly reduced the risk of recurrence of manic or mixed mood episodes over one year vs placebo6

Other secondary endpoints:Other secondary endpoints:recurrence of manic, mixed, and mixed/manic mood episodesrecurrence of manic, mixed, and mixed/manic mood episodes⁶⁶reduced risk of recurrence of mixed/manic mood episodes vs placebo (HR=0.249 [95% CI, P0.137-0.451], <0.0001)75%Significantly delayed time to recurrence for a manic episode (HR=0.259 [95% CI, 0.136-0.495], <0.0001) or Pmixed episode (HR=0.202 [95% CI, 0.044-0.939], =0.0237)P
Significantly delayed time to recurrence for a manic episode (HR=0.259 [95% CI, 0.136-0.495], <0.0001) or Pmixed episode (HR=0.202 [95% CI, 0.044-0.939], =0.0237)P75%reduced risk of recurrence of mixed/manic mood episodes vs placebo (HR=0.249 [95% CI, 0.137-0.451], <0.0001)POther secondary endpoints:Other secondary endpoints:recurrence of manic, mixed, and mixed/manic mood episodesrecurrence of manic, mixed, and mixed/manic mood episodes⁶⁶

No substantial difference in the time to a depressive episode (HR=0.932 [95% CI, 0.497-1.747], P=0.8247)6

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

IMPORTANT WARNING AND PRECAUTION REGARDING 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 anti-diabetic 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.

The safety profile of ABILIFY ASIMTUFII was comparable to that seen with ABILIFY MAINTENA.

Safety Data

Non-pivotal analyses

ABILIFY MAINTENA® (aripiprazole) exposure response analysis

ABILIFY MAINTENA treatment in adult patients living with schizophrenia1*

The exposure-response analysis reported below was funded by Otsuka Pharmaceutical Development & Commercialization, Inc.

The exposure-response time to relapse analysis used data from two Phase 3 clinical studies and included 615 subjects living with schizophrenia. Of these subjects, 120 were administered oral aripiprazole only, and 495 subjects were administered ABILIFY MAINTENA gluteally. Patients receiving ABILIFY MAINTENA also received 14 days of oral aripiprazole at initiation. Exposure-response analysis of time to relapse included 85 impending relapse events (48 events for placebo and 37 events for ABILIFY MAINTENA) and 530 censored subjects (72 subjects for placebo and 458 subjects for ABILIFY MAINTENA).1

Median pharmacokinetic data were studied in ABILIFY MAINTENA and oral aripiprazole. Caution should be taken in the interpretation of these data.

Predicted minimum
aripiprazole concentration

Aripiprazole plasma concentration (ng/mL) 2001000Subjects with a diagnosis of schizophrenia and a predicted aripiprazole C ≥95 ng/mL are more than 4 times less likely to relapse with the use of ABILIFY MAINTENASubjects with a diagnosis of schizophrenia and a predicted aripiprazole C ≥95 ng/mL are more than 4 times less likely to relapse with the use of ABILIFY MAINTENAminmin††¹¹95 ng/mL0100200300400Time (days)
Aripiprazole plasma concentration (ng/mL) 2001000Subjects with a diagnosis of schizophrenia and a predicted aripiprazole C≥95 ng/mL are more than 4 times less likely to relapse with the use of ABILIFY MAINTENASubjects with a diagnosis of schizophrenia and a predicted aripiprazole C≥95 ng/mL are more than 4 times less likely to relapse with the use of ABILIFY MAINTENAminmin††¹¹95 ng/mL0100200300400Time (days)

*Adapted from Wang X, et al. Clinical Pharmacology in Drug Development. 2022;11(2):150-164.

†Subjects with Cmin ≥95 ng/mL are 4.41 times less likely to relapse vs subjects with a predicted Cmin <95 ng/mL with the use of ABILIFY MAINTENA.1

IMPORTANT WARNING AND PRECAUTION REGARDING 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 anti-diabetic treatment despite discontinuation of the suspect drug. (cont'd)
 

32-week pharmacokinetic simulation

From initiation, ABILIFY ASIMTUFII showed similar aripiprazole concentrations to ABILIFY MAINTENA

Median simulated aripiprazole plasma concentrations were similar
to ABILIFY MAINTENA from initiation through 32 weeks2‡

ABILIFY ASIMTUFIIABILIFY MAINTENAAripiprazole plasma
concentration (ng/mL)400300200100014 days of oral aripiprazole overlap48121620242832Time (weeks)
ABILIFY ASIMTUFIIABILIFY MAINTENAAripiprazole plasma concentration (ng/mL)400300200100014 days of oral aripiprazole overlap48121620242832Time (weeks)

IMPORTANT WARNING AND PRECAUTION REGARDING METABOLIC CHANGES (cont'd)
Atypical antipsychotic drugs have caused metabolic changes including:

  • 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.

‡Based on a simulation population of N=1000.

The safety profile of ABILIFY ASIMTUFII was comparable to that seen with ABILIFY MAINTENA.

Safety Data