A new DRUG TRIALS SNAPSHOT is now available.
INGREZZA is a drug for the treatment of tardive dyskinesia.
Tardive dyskinesia is a condition characterized by uncontrolled, repetitive, involuntary movements of the face, tongue, arms, legs, and other body parts often caused by long-term use of some psychiatric drugs, such as antipsychotics.
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: INGREZZA
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.
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 INGREZZA Prescribing Information for complete information.
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 INGREZZA Prescribing Information for complete information.
INGREZZA (valbenazine)
(in greh' zah)
Neurocrine Biosciences
Approval date: April 11, 2017
(in greh' zah)
Neurocrine Biosciences
Approval date: April 11, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
INGREZZA is a drug for the treatment of tardive dyskinesia.
Tardive dyskinesia is a condition characterized by uncontrolled, repetitive, involuntary movements of the face, tongue, arms, legs, and other body parts often caused by long-term use of some psychiatric drugs, such as antipsychotics.
How is this drug used?
INGREZZA is a capsule taken by mouth once a day.
What are the benefits of this drug?
Patients who received INGREZZA had improvement in the severity of tardive dyskinesia compared to those who received placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: INGREZZA worked similarly in men and women.
- Race: INGREZZA worked similarly in White and Black or African American patients. Differences among other races could not be determined because of the small number of patients.
- Age: INGREZZA worked similarly in patients below and above 65 years of age.
What are the possible side effects?
The most common side effect of INGREZZA is sleepiness, which can sometimes impair the ability to drive a car.
INGREZZA may cause serious heart rhythm problems (QT prolongation).
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in women and men.
- Race: The occurrence of side effects was similar in White and Blacks or African American patients. Differences among other races could not be determined because of the small number of patients.
- Age: The occurrence of side effects was similar in patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved INGREZZA based primarily on evidence from three clinical trials that included 445 patients with tardive dyskinesia. These patients represent the population that was used to assess the side effects of INGREZZA (safety population) and will be presented below. One of the three trials provided evidence for the benefits of INGREZZA at the approved dosage, and information from this trial is presented under MORE INFO in Table 8.
The trials were conducted in USA, Canada and Puerto Rico.
The figure below summarizes how many men and women were in all three clinical trials together.
Figure 1. Baseline Demographics by Sex (safety population)
FDA Clinical review
Figure 2 and Table 1 below summarize the percentage of patients by race in all three clinical trials together.
Figure 2. Baseline Demographics by Race (safety population)
FDA Clinical review
Table 1. Baseline Demographics by Race (safety population)
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 254 | 57 |
| Black or African American | 172 | 39 |
| Asian | 1 | less than 1 |
| American Indian or Alaska Native | 3 | 1 |
| Native Hawaiian or Other Pacific Islander | 2 | less than 1 |
| Mixed | 5 | 1 |
| Other | 8 | 2 |
FDA Clinical review
Figure 3 summarizes the percentage of patients by age group in all three clinical trials together.
Figure 3. Baseline Demographics by Age (safety population)
Clinical trial data
How were the trials designed?
There were three trials that evaluated the side effects of INGREZZA. In all three trials patients were randomly assigned to receive either INGREZZA or placebo once daily for 6 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.
One of these three trials was used to evaluate benefits of INGREZZA at the recommended dosage. The benefit of INGREZZA was evaluated by measuring the change in severity of tardive dyskinesia from baseline to the end of week 6 using the Abnormal Involuntary Movement Scale (AIMS). Using this scale, the total score could range from 0 to 28, with a decrease in score indicating improvement.
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.
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.
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