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Brexpiprazole Fumarate

Brexpiprazole Fumarate, also known as OPC-34712FUM, is being studied in clinical trials for its potential in treating schizophrenia. These trials are investigating various aspects of the drug, including its once-weekly (QW) formulation, its effectiveness in managing acute symptoms, and its long-term safety and tolerability. The studies also examine how food intake affects the drug’s performance in the body and its overall efficacy compared to a placebo.

Table of Contents

What is Brexpiprazole Fumarate?

Brexpiprazole Fumarate, also known as OPC-34712FUM, is a medication being studied for the treatment of schizophrenia. Schizophrenia is a serious mental health condition that affects a person’s thoughts, feelings, and behaviors. This medication is part of a new generation of antipsychotic drugs designed to help manage the symptoms of schizophrenia more effectively.[1][2][3]

What Conditions Does Brexpiprazole Fumarate Treat?

Based on the clinical trials information provided, Brexpiprazole Fumarate is primarily being studied for the treatment of:

  • Schizophrenia: This is a chronic mental disorder that affects how a person thinks, feels, and behaves. People with schizophrenia may experience hallucinations, delusions, and disorganized thinking.[1][2]
  • Acute Schizophrenia: This refers to a phase of schizophrenia where symptoms are severe and may require immediate treatment.[3]
The medication is being tested to see how well it can manage both long-term symptoms and acute episodes of schizophrenia.

Dosage Forms and Administration

Brexpiprazole Fumarate is being developed as a once-weekly (QW) formulation. This means that patients would only need to take the medication once a week, which could be more convenient than daily medications. The current dosage forms being studied include:

  • 24 mg tablets
  • 48 mg weekly dose (two 24 mg tablets taken together)
In some studies, patients start with a lower dose of 24 mg (one tablet) and then increase to 48 mg (two tablets) after the first week.[1][2][3]

Ongoing Research and Clinical Trials

Several clinical trials are currently underway to study different aspects of Brexpiprazole Fumarate:

  1. Food Effect Study: This trial is investigating how food affects the way the body processes Brexpiprazole. Researchers are comparing how the medication works when taken with food versus when taken on an empty stomach.[1]
  2. Long-term Administration Trial: This study is looking at the safety and effectiveness of Brexpiprazole when used for an extended period (52 weeks) in patients with schizophrenia.[2]
  3. Acute Schizophrenia Trial: This trial is testing how well Brexpiprazole works in treating acute symptoms of schizophrenia compared to a placebo (a substance with no active medication).[3]
These studies will help researchers understand how best to use Brexpiprazole in treating schizophrenia.

Effects of Food on Brexpiprazole

One of the ongoing studies is specifically looking at how food affects the way Brexpiprazole works in the body. This is important because some medications can work differently when taken with or without food. The study is measuring:

  • Maximum plasma concentration (Cmax): This is the highest level of the drug in the blood after taking a dose.
  • Area Under Curve (AUC): This measures the total exposure to the drug over time.
By comparing these measurements when the drug is taken with food versus on an empty stomach, researchers can determine if patients should take Brexpiprazole with meals or not.[1]

Long-term Use and Safety

A 52-week study is being conducted to assess the long-term effects of Brexpiprazole. This trial aims to:

  • Confirm the tolerability of the medication when used for an extended period
  • Assess the safety of long-term use
  • Evaluate the effectiveness of Brexpiprazole in managing schizophrenia symptoms over time
The primary measure in this study is the frequency of Adverse Events, which are any unfavorable and unintended signs, symptoms, or diseases that occur during the study period. This information will help doctors understand the potential risks and benefits of long-term Brexpiprazole use.[2]

Efficacy Studies in Acute Schizophrenia

A specific trial is focusing on how well Brexpiprazole works in treating acute schizophrenia. This study:

  • Compares Brexpiprazole to a placebo
  • Lasts for 7 weeks
  • Measures changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS)
The PANSS is a standardized tool used to measure the severity of symptoms in schizophrenia. By comparing the change in PANSS scores between patients taking Brexpiprazole and those taking a placebo, researchers can determine how effective the medication is in treating acute schizophrenia symptoms.[3]

Aspect Details
Drug Name Brexpiprazole Fumarate (OPC-34712FUM)
Condition Studied Schizophrenia (including acute schizophrenia)
Formulation Once-weekly (QW) tablets
Dosages Tested 24 mg and 48 mg
Study Types Food effect study, Long-term safety and efficacy, Acute symptom management
Primary Outcomes Measured Pharmacokinetics (Cmax, AUC), Adverse Events, PANSS score changes
Study Durations 7 weeks (acute study), 52 weeks (long-term study)
Key Features Once-weekly dosing, Placebo-controlled trials, Food effect analysis

FAQ

  • What is Brexpiprazole Fumarate? Brexpiprazole Fumarate, also known as OPC-34712FUM, is a medication being studied for the treatment of schizophrenia. It is being developed as a once-weekly (QW) formulation, which means patients would only need to take it once a week.
  • How is the effect of food on Brexpiprazole Fumarate being studied? One study is investigating how food affects the way the body processes Brexpiprazole Fumarate. Participants take the medication both while fasting and after eating a high-fat meal. Researchers then measure the drug's concentration in the blood to understand how food impacts its absorption and effectiveness.
  • What is being studied in the long-term trial of Brexpiprazole Fumarate? A long-term trial is being conducted to assess the tolerability, safety, and effectiveness of Brexpiprazole Fumarate when taken once weekly for 52 weeks. This study aims to understand how patients with schizophrenia respond to the medication over an extended period.
  • How is the effectiveness of Brexpiprazole Fumarate being measured in acute schizophrenia? In a trial for acute schizophrenia, researchers are comparing Brexpiprazole Fumarate to a placebo. They are measuring changes in symptoms using a scale called the Positive and Negative Syndrome Scale (PANSS). This helps determine if the medication is effective in managing acute symptoms of schizophrenia.
  • What dosages of Brexpiprazole Fumarate are being tested in these trials? The trials are testing various dosages, including 24 mg and 48 mg formulations. In some studies, participants start with a lower dose (24 mg) and then increase to a higher dose (48 mg) over time. This helps researchers understand the most effective and safe dosage for patients.

Ongoing Clinical Trials on Brexpiprazole Fumarate

  • A Study Testing Brexpiprazole Given Once Weekly to Treat Sudden Worsening of Symptoms in Patients with Schizophrenia

    Recruiting

    1 1 1
    Investigated drugs:
    Romania

Glossary

  • Schizophrenia: A serious mental disorder characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Cmax: The maximum concentration of a drug in the blood after it has been administered.
  • AUC (Area Under Curve): A measure of the total exposure to a drug over time, used to assess how much of the drug is in the body.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect, used as a control in clinical trials.
  • PANSS (Positive and Negative Syndrome Scale): A medical scale used to measure the severity of symptoms in patients with schizophrenia.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Adverse Events: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Monotherapy: Treatment with a single drug.
  • Efficacy: The ability of a drug or treatment to produce the desired effect.

References