Drug updated on 4/18/2024
| 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 adults with schizophrenia.
Summary
- Aripiprazole lauroxil (Aristada) is indicated for the treatment of adults with schizophrenia and has been noted as a long-acting injectable depot formulation, providing an effective option particularly for patients who struggle with oral treatment adherence.
- Four studies were reviewed to gather information on Aristada's safety and effectiveness in comparison to other antipsychotic drugs.
- Aristada was found to be well-tolerated, presenting low rates of motor side effects and metabolic adverse effects, which are common issues associated with many alternative antipsychotics. Some side effects such as akathisia and tremor occur at higher rates compared to placebo but remain uncommon overall.
- Compared against placebo, oral antipsychotics (OAPs), and other long-acting injectables (LAIs), Aristada demonstrated superiority over placebos in preventing relapse and hospitalization, while showing comparable results against OAPs regarding all-cause discontinuation, functionality, quality of life, and tolerability, along with higher patient satisfaction levels.
- Both monohydrate and lauroxil formulations showed efficacy in reducing relapses of schizophrenia symptoms long-term among stabilized patients while also improving acute symptoms. This suggests that Aristada could play a significant role not only in maintenance therapy for schizophrenia but potentially for bipolar disorder too.
- Despite its favorable reception, further research conducted within real-world settings would help substantiate these findings more clearly, especially across diverse populations or subgroups, thereby optimizing personalized treatment strategies within schizophrenia management.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aristada (aripiprazole lauroxil) Prescribing Information. | 2021 | 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 |