Levels of aripiprazole in the blood with an injection of aripiprazole administered once every two months: a plain language summary of publication

What is this summary about? 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. Why was this research done? 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. What were the results? 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. What do the results mean? 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.