Drug updated on 9/4/2024
| 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
- Aristada (aripiprazole lauroxil) is indicated for the treatment of schizophrenia in adults.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Effectiveness in Schizophrenia: Aripiprazole (including aripiprazole lauroxil) is effective in treating schizophrenia, reducing relapses, and improving symptoms in acute episodes. LAIs, including aripiprazole lauroxil, consistently outperform placebo in preventing relapse and hospitalization.
- Effectiveness in Bipolar Disorder: Aripiprazole LAI formulations (monohydrate and lauroxil) are effective in reducing relapse and maintaining stabilization in bipolar disorder.
- Comparative Effectiveness: LAIs, including aripiprazole lauroxil, are partly superior to oral antipsychotics (OAPs) in preventing relapse and hospitalization, and comparable to other LAIs in preventing relapse and hospitalization.
- Aripiprazole is generally well-tolerated with low rates of motor side effects and metabolic adverse effects. Higher rates of akathisia and tremor compared to placebo are noted, but these effects remain uncommon (10-11% or less). Benefits include reduced serum prolactin levels and QTc interval.
- LAIs, including aripiprazole lauroxil, were comparable to oral antipsychotics (OAPs) regarding tolerability, with no significant differences in safety outcomes between LAIs and OAPs.
- 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 |
|---|---|---|
| New antipsychotic medications in the last decade. | 2021 | Current Psychiatry Reports |
| 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 |
|---|---|---|
| Florida best practice psychotherapeutic medication guidelines for adults. | 2023 | Florida Center for Behavioral Health Improvements and Solutions |
| 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 |