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What is Rexulti used for and how well does it work?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Oct 20, 2020.

Official Answer

by Drugs.com

Key Points

Rexulti (generic name: brexpiprazole) is an atypical antipsychotic used to treat adults with schizophrenia or depression. Rexulti is classified as a serotonin-dopamine activity modulator (SDAM) and is thought to work by adjusting the balance of natural chemicals in your brain.

Rexulti is given as an oral tablet once daily and may be used alone or with other medicines for the treatment of schizophrenia. It is also used in combination with an antidepressant for patients with depression (major depressive disorder). It comes in strengths of 0.25 milligrams (mg), 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

An imbalance of neurotransmitters is thought to be linked to several mental health conditions, including depression and schizophrenia.

  • Rexulti works by adjusting the imbalance of natural chemicals in the brain to help lower symptoms of these diseases.
  • These chemicals, such as dopamine and serotonin, are called neurotransmitters.
  • Neurotransmitters help certain cells to communicate with each other.

What is schizophrenia and depression?

Depression is a long-term, serious mood disorder that can affect your daily feelings, actions and thoughts. Depression is sometimes called major depressive disorder (MDD). Depression can cause profound, long-lasting feelings of sadness, tearfulness, loss of interest in daily activities, and often withdrawal from family and friends. In the most severe cases, thoughts of worthlessness, self-harm or suicide may occur.

Schizophrenia is also a serious mental health disorder that alters how your brain interprets reality and your surroundings. You may see, hear or believe things that are not real. Your thoughts can be difficult to organize and you may have trouble in social or working environments, affecting your daily functioning.

Rexulti is an oral tablet you take once a day with or without food. Your doctor will slowly increase your dose over a few weeks based on how well you respond to and tolerate the medicine.

How well does Rexulti work?

Depression

If you have been taking an antidepressant for at least 2 months but are still having symptoms of depression, adding Rexulti to your treatment regimen may be helpful. In a 6-week long study in adults, adding Rexulti to ongoing antidepressant treatment led to a 62% greater reduction in symptoms of depression.

In two depression studies, the effect of treatment was measured using the Montgomery-Asberg Depression Rating Scale (MADRS), a common tool that looks at symptoms of depression such as sad feelings, attention, sleep patterns and appetite. About half of all of patients in the 2 trials also had symptoms of anxiety.

Patients received doses ranging from 1 to 3 mg/day or placebo (an inactive treatment), plus an antidepressant (SSRI or SNRI) treatment (ADT). When compared to score changes with the placebo + ADT, MADRS total scores dropped by:

  • -1.3 points (with the 1 mg/day + ADT)
  • -2 points (using the 3 mg/day + ADT)
  • -3.2 points (using the 2 mg/day + ADT)

Compared to placebo, only the 2 mg/day dose was found to have a statistically significant effect on MADRS score. For most patients with depression, the target dose of Rexulti is 2 mg once daily.

Schizophrenia

Rexulti has also been shown to be effective for adults with schizophrenia when compared to a placebo in two 6-week long studies. Patients were diagnosed with an acute exacerbation of schizophrenia who could benefit from hospitalization or continued hospitalization. Researchers determine the effectiveness of Rexulti using the Positive and Negative Syndrome Scale (PANSS) total symptom severity score, a common scoring tool used in the study of schizophrenia.

Overall, at the end of 6 weeks, the PANSS symptom score from baseline for patients taking Rexulti had declined significantly for both doses. In one study, there was a significant decline in PANSS score of:

  • 20.7 points (2 mg/day) with Rexulti compared to a reduction of 8.7 points with placebo.
  • 19.7 points (4 mg/day) with Rexulti compared to a reduction of 7.6 points with placebo.

Statistical significance was not achieved for the primary endpoint with either the 1-mg/day dose or the 2-mg/day dose compared with placebo in one study. The recommended target dose for Rexulti is 2 mg to 4 mg once daily in patients with schizophrenia.

Warnings

Antipsychotic medicines like Rexulti can raise the risk of death in elderly patients who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Rexulti is not approved for the treatment of patients with dementia-related psychosis.

There are many other important warnings, side effects and drug interactions associated with Rexulti treatment. Speak with your doctor about the safety of Rexulti before you begin treatment. Be sure to tell your doctor and pharmacist about all of the medicines you take, including prescription, over-the-counter, herbal products and vitamin supplements.

Bottom Line

  • Rexulti (brexpiprazole), an atypical antipsychotic, is used with an antidepressant medicine to treat adult patients diagnosed with major depressive disorder (depression) or with schizophrenia.
  • Rexulti is thought to work by adjusting the balance of natural chemicals (neurotransmitters) in your brain such as dopamine and serotonin. An imbalance of neurotransmitters is thought to be linked to several mental health conditions, including depression and schizophrenia.
  • In placebo-controlled studies, Rexulti at target doses was shown to have a significant effect on symptom severity in patients with either depression or schizophrenia.

This is not all the information you need to know about Rexulti (brexpiprazole) for safe and effective use. Review the full Rexulti information here, and discuss this information and any questions with your doctor or other health care provider.

References
  • Rexulti (brexpiprazole) [product information]. Otsuka Pharmaceutical Co. Rockville, MD. March 2020. Accessed Oct. 19, 2020 at https://www.otsuka-us.com/media/static/Rexulti-PI.pdf
  • Rexulti.com. Efficacy data for Rexulti. Accessed Oct. 19, 2020 at https://www.rexultihcp.com.

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