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  4. Drug Trials Snapshots: BARHEMSYS
  1. Development & Approval Process | Drugs

Drug Trials Snapshots: BARHEMSYS

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the BARHEMSYS Prescribing Information for complete information.

BARHEMSYS (amisulpride)
bah - rem’ - sis     
Acacia Pharma.
Approval date: February 26, 2020


DRUG TRIALS SNAPSHOT SUMMARY: 

What is the drug for?

BARHEMSYS is a drug used in adults to prevent or treat postoperative nausea and vomiting (PONV). It is to be used:

  • for prevention of PONV either alone, or together with a different drug for PONV prevention
  • for treatment of PONV in patients who have not received any drug for the prevention of PONV, or those who have received a different drug for the prevention for PONV

How is this drug used?

BARHEMSYS is an injection given directly into the vein (intravenous infusion) by a healthcare professional over 1-2 minutes

What are the benefits of this drug?

Patients taking BARHEMSYS experienced less nausea/vomiting and less need for additional medication to prevent or treat PONV in comparison to patients receiving placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex:  BARHEMSYS worked similarly in men and women.
  • Race:  The majority of patients were White; therefore, differences in how the drug worked among races could not be determined.
  • Age:  BARHEMSYS worked similarly in patients younger than 65 years and patients 65 years and older.

What are the possible side effects?

BARHEMSYS may cause serious heart rhythm problems due to prolongation of heart electrical activity (QT prolongation).

The most common side effects of BARHEMSYS are increased level of prolactin hormone in blood, chills, low serum potassium level, low blood pressure during infusion, and abdominal distension and infusion site pain.

 

Were there any differences in side effects among sex, race, and age?

  • Sex:  The occurrence of side effects was similar in men and women.
  • Race:  The majority of patients were White. Therefore, differences in side effects among races could not be determined.
  • Age:  The occurrence of side effects was similar in patients below 65 years of age and those 65 years and above.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved BARHEMSYS based on evidence from 4 clinical trials of 2323 patients undergoing surgery or experiencing nausea and vomiting after the surgery. The trials were conducted at 80 sites in the United States, Canada and Europe.

The figure below summarizes how many men and women were in the clinical trials.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 2034 women (88%) and 289 men (12%) participated in the clinical trial.

Clinical Trial Data

The figure and table below summarize the percentage of patients by race in the clinical trials.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 1845 White (79%), 33 Asian (1%) and 220 Black or African American  (10%),  5 American Indian or Alaska Native (10%) and 220 Other (10%).

Clinical Trial Data

The figure below sumarizes the percentage of patients by age in the clinical trials.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  1256 (42%) were less than 65 years, 1275 (42%) of patients were 65 to 74 year and 478 (16%) were 75 years and older.

Clinical Trial Data

The figure below sumarizes the percentage of patients by ethnicity in the clinical trials.

Figure 4. Demographics by Ethnicity

Pie charts summarizing how many individuals of certain ethnicity were enrolled in the clinical trial. In total,  226 patients were Hispanic or Latino (10%), and 1239 patients were not Hispanic or Latino (53%) and 858 patients were Not Reported (37%).

Clinical Trial Data

How were the trials designed?

There were four trials that evaluated the benefits and side effects of BARHEMSYS.

Two trials (Trials 1 and 2) enrolled patients scheduled to have surgery.  Patients were randomly assigned to receive either BARHEMSYS or a placebo drug at the beginning of general anesthesia. In Trial 1, patients received BARHEMSYS or placebo alone, and in Trial 2, they received BARHEMSYS or placebo in combination with one medication approved for prevention of nausea and vomiting. Neither the patients nor the health care providers knew which treatment was being given until after the trial was complete.

The trials counted the number of patients who had no vomiting and did not use additional medications for nausea or vomiting in the first day (24 hours) after the surgery.  The results then compared BARHEMSYS to placebo.

The other two trials (Trials 3 and 4) enrolled patients who were experiencing nausea and vomiting after surgery.  In Trial 3, patients did not receive any medication to prevent nausea and vomiting before surgery and in Trial 4 they received the medication, but the treatment did not work. In both trials, patients were randomly assigned to receive either BARHEMSYS or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trial was complete.

The trials counted the number of patients who had no vomiting and did not use additional medications for nausea or vomiting in the first day (24 hours) after the treatment. The trial compared BARHEMSYS to placebo.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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