A new DRUG TRIALS SNAPSHOT is now available
Drug Trials Snapshots: ORILISSA
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 the ORILISSA Package Insert 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 the ORILISSA Package Insert for complete information.
ORILISSA (elagolix)
awr-ah-lih-sah
Abbvie, Inc.
Approval date: July 23, 2018
awr-ah-lih-sah
Abbvie, Inc.
Approval date: July 23, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ORILISSA is a drug for the treatment of moderate to severe pain associated with endometriosis.
How is this drug used?
ORILISSA is a tablet and is available in two strengths. The lower strength tablet is taken once daily for no more than 24 months. The higher strength tablet is taken twice daily for no more than 6 months. Longer use is not recommended because of bone loss.
What are the benefits of this drug?
Both dose strengths of ORILISSA reduced pain during and between menstrual periods after 3 months of treatment.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: All patients in the trials were women.
- Race: The majority of patients in the trials were White. Differences in how well ORILISSA worked among races could not be determined from the information available.
- Age: Patients in the trials were between 18 and 49 years of age. ORILISSA worked similarly across all age groups tested.
What are the possible side effects?
ORILISSA may cause serious side effects including bone loss, suicidal thoughts or behaviors, worsening of mood including depression and anxiety, menstrual bleeding changes that could make it hard to detect pregnancy, and abnormal liver tests.
ORILISSA may also increase the risk of early pregnancy loss.
The most common side effects are hot flushes and night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression and mood changes.
Were there any differences in side effects among sex, race and age?
- Sex: All patients in the trials were women.
- Race: The majority of patients in the trials were White. Differences in side effects among races could not be determined from the information available.
- Age: Patients in the trials were between 18 and 49 years of age. The occurrence of side effects was similar across all age groups tested.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved ORILISSA based on evidence from two clinical trials (NCT01620528/Trial 1 and NCT01931670/Trial 2) of 1686 patients with moderate to severe pain associated with endometriosis. The trials were conducted at 338 sites in Canada, Europe, Latin America, South Africa, and the United States.
Figure 1 summarizes the percentage of patients by sex enrolled in the combined clinical trials used to evaluate efficacy and safety.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 summarizes the percentage of patients by race enrolled in the in the combined clinical trials used to evaluate efficacy and safety.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics of Trials by Race
| Race | Number of Patients | Percentage of Patients |
|---|---|---|
| White | 1486 | 88% |
| Black or African American | 148 | 9% |
| Asian | 16 | 1% |
| Other | 36 | 2% |
FDA Review
Figure 2 summarizes the percentage of patients by age enrolled in the clinical trials used to evaluate efficacy and safety.
Figure 2. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit and side effects of ORILISSA were evaluated in two clinical trials. Trials 1 and 2 enrolled patients who had moderate to severe pain associated with endometriosis. Patients were randomly assigned to receive one of two doses of ORILISSA or placebo daily for 6 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.
Patients rated their pain during and between menstrual periods taking into account whether the pain affected daily activity. Patients used a numerical scale to score how severe the pain was and how much the pain affected their daily activity. The scores for the patients receiving ORILISSA were compared to the scores for the patients who received 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.
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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