Aripiprazole IM depot as an option for the treatment of bipolar disorder

ABSTRACT

Introduction: Long-acting injectable (LAI) antipsychotic drugs are developed to reduce daily intake need and to overcome treatment non-adherence. Aripiprazole IM depot refers to two long-acting aripiprazole formulations, once monthly monohydrate (AOM) and aripiprazole lauroxil. AOM has been approved for schizophrenia since 2012 and for bipolar disorder since 2017. Aripiprazole lauroxil is approved for schizophrenia, not for bipolar disorder.

Areas covered: To assess the effect of AOM in bipolar disorder, the authors searched PubMed and ClinicalTrials.gov for randomized trials using AOM in patients with bipolar disorder. Included were four studies covering efficacy, functioning, quality of life, and safety/tolerability. Studies lasted 12 months.

Expert opinion: AOM reduced symptoms of patients with bipolar disorder and a manic episode, increased functioning and quality of life, and protected from recurrence of manic episodes. It proved to be safe/tolerable, with only akathisia occurring in ≥10% of cases and more frequently than with placebo. However, there were only 143 patients receiving AOM in the considered studies. Included studies were backed in their conclusions by other literature, but they come from 2017–2018. No studies are expected or planned in the near future. Aripiprazole lauroxil has not applied for approval in bipolar disorder and there is no sign it will.

KEYWORDS:

• Aripiprazole Once Monthly
• aripiprazole Lauroxil
• bipolar Disorder
• long-Acting Injectable Antipsychotic Drugs

Article Highlights

• Aripiprazole long-acting injectable has been developed for treating schizophrenia

• The drug has proved to be effective in the acute manic phase of bipolar disorder

• Studies supporting its use in bipolar disorder are few, but the evidence is robust

• Of the two available formulations, evidence regards only the monohydrate

• There is need for more studies, but the field appears to be idle recently

Acknowledgments

We acknowledge the help of Dr. Emanuela Amici in critically reviewing our manuscript.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer has been a consultant to or has received honoraria or grants from Janssen-Cilag, Lundbeck, Otsuka, Exeltis and Pfizer Inc. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper received no funding.