Drug updated on 10/31/2024
| Dosage Form | Extended-release injectable suspension (intramuscular; 441 mg, 662 mg, 882 mg, 1064 mg) |
| Drug Class | Atypical antipsychotics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of schizophrenia in adults.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Relapse and Symptom Reduction: Aripiprazole lauroxil LAI (long-acting injectable) formulations, including both monohydrate and lauroxil types, were effective in reducing relapses and recurrence in schizophrenia and bipolar disorder, outperforming placebo and lower-dose monohydrate formulations. Additionally, these formulations improved symptoms in acute schizophrenia cases.
- Hospitalization Prevention: Aripiprazole lauroxil demonstrated efficacy over placebo in preventing relapse and hospitalization in long-term treatment settings for schizophrenia and bipolar disorder.
- Comparison to Oral Antipsychotics and Other LAIs: Aripiprazole lauroxil showed partial superiority over oral antipsychotics in relapse and hospitalization prevention, while effectiveness in preventing relapse and hospitalization was comparable to other LAIs such as risperidone and paliperidone.
- Adverse Effects: Aripiprazole lauroxil is generally well-tolerated, showing low rates of motor side effects and lower metabolic adverse effects compared to other antipsychotics. Akathisia and tremor occur more frequently than placebo but remain uncommon, with incidences of 10-11% or less.
- Unique Safety Characteristics: Aripiprazole is associated with reduced serum prolactin levels and a decreased QTc interval, distinguishing it from other antipsychotic treatments.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aristada (aripiprazole lauroxil) Prescribing Information. | 2023 | Alkermes, Inc., Waltham, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| A safety evaluation of aripiprazole in the treatment of schizophrenia | 2020 | Expert Opinion on Drug Safety |
| Long-Acting Injectable (LAI) Aripiprazole Formulations in the Treatment of Schizophrenia and Bipolar Disorder: a Systematic Review | 2019 | Clinical Drug Investigation |
| Long-Acting Injections in Schizophrenia: a 3-Year Update on Randomized Controlled Trials Published January 2016–March 2019 | 2019 | Current Psychiatry Reports |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Practical guidance for the use of long-acting injectable antipsychotics in the treatment of schizophrenia | 2022 | Psychology Research and Behavior Management |
| The American Psychiatric Association practice guideline for the treatment of patients with schizophrenia, third edition | 2021 | The American Psychiatric Association |
| Best practices for aripiprazole lauroxil administration: from formulation development to injection technique | 2019 | Journal of Psychiatric Practice |