Abstract
Summary
The information summarized here relates to aripiprazole, a medicine that is used to treat conditions such as schizophrenia and bipolar I disorder. Researchers wanted to understand what levels of aripiprazole in the blood looked like following an injection of aripiprazole administered once every 2 months. They did this using a method known as population pharmacokinetics.
Researchers conduct clinical trials when developing new medicines to see how well they work and how safe they are. Clinical trials cannot cover every possible real-life scenario. Researchers can address this by performing population pharmacokinetic modeling and simulation, a process that involves computers and specialized software.
Population pharmacokinetic modeling combines information from many people to show how a medicine is absorbed, distributed, broken down, and cleared from the body. It is also done to understand why these processes might vary between people. After the model is built, it can be used to simulate (estimate) the level of the medicine in the blood in situations not tested in clinical trials.
Simulations showed that an injection of aripiprazole given once every 2 months results in effective drug levels that last until the next dose is due. Drug levels with aripiprazole given once every 2 months are similar to those with injections of aripiprazole given once-monthly, but with fewer injections.
The results provide insight into aripiprazole levels in the blood in people newly starting or continuing treatment with aripiprazole once every 2 months. They add to information already collected in clinical trials. The findings supported the approval of aripiprazole once every 2 months in people living with schizophrenia or bipolar I disorder. They also helped inform the guidance that doctors follow when they prescribe the drug to their patients. The availability of aripiprazole once every 2 months may make treatment easier, and help people stick to their treatment over time.
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Footnotes
Acknowledgements
Medical writing support was provided by Lyndal Staples, BSc, and editorial support was provided by Isabella Cannava, BA, of the Prime Group of Companies (Knutsford, UK); this was funded by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S.
Ethics approval and consent to participate
The population pharmacokinetic model was built using data from people treated with various formulations of aripiprazole across ten clinical trials. All of the trials were checked and approved by independent ethics committees/institutional review boards to make sure they were conducted properly. Everyone who took part, or their legal guardians, gave written permission before the trials began.
Author contribution(s)
Yanlin Wang, Matthew Harlin, Frank Larsen, Xiaofeng Wang, Wansu Park, Benjamin Rich, Jogarao V. Gobburu and Arash Raoufinia: writing – original draft; writing – review and editing.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article:
● This analysis was sponsored by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S.
● The two companies were involved in the design of the analysis, the collection and interpretation of the data, the writing and reviewing of this summary, and the decision to submit the summary for publication.
Conflict of interest statement
Yanlin Wang, Matthew Harlin, and Arash Raoufinia are full-time employees of Otsuka Pharmaceutical Development & Commercialization, Inc. Xiaofeng Wang was a full-time employee of Otsuka Pharmaceutical Development & Commercialization Inc. at the time the analysis was conducted. Frank Larsen was a full-time employee of Lundbeck A/S, Valby, Denmark at the time the analysis was conducted. Wansu Park is a full-time employee of Alnylam Pharmaceuticals. Wansu Park and Benjamin Rich were paid consultants for Otsuka Pharmaceutical Development & Commercialization, Inc. at the time the analysis was conducted. Jogarao V. Gobburu is a cofounder of Pumas-AI Inc. and Vivpro Corp.
