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          Drug Trials Snapshots: ORILISSADrug Approvals and Databases Drug Trials Snapshots: ORILISSA
  
  	
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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.
**ORILISSA** (elagolix)
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.
MORE INFO
**What are the benefits of this drug (results of trials used to assess efficacy)?**
The tables below summarize efficacy results for the evaluated patients for Trials 1 and 2. The co-primary outcome was the proportion of responders for moderate to severe dysmenorrhea (pain during menstrual periods) and pelvic pain not related to menses (non-menstrual pelvic pain) after 3 months of treatment.
**Table 2. Proportion of Responders† for Dysmenorrhea and Non-Menstrual Pelvic Pain at Month 3 in Trial 1 and Trial 2, Using the Endometriosis Daily Pain Impact Scale**
Trial 1
            Trial 2ORILISSA
            Placebo
            ORILISSA
            Placebo150 mg
            once daily
            N=248
            200 mg
            twice daily
            N=244
            N=373
            150 mg
            once daily
            N=221
            200 mg
            twice daily
            N=225
            N=353Dysmenorrhea 
            Difference from placebo
            46% 
            27%**
            76% 
            56%**
            20%
            43% 
            21%**
            72% 
            50%**
            23%Non-Menstrual Pelvic Pain
            Difference from placebo
            50%   
            14%**
            55%   
            18%**
            36%
            50%   
            13%**
            58%   
            21%**
            37%
† Trial 1-1-Dysmenorrhea responder threshold: at least 0.81 point decrease from baseline in dysmenorrhea score; Non-Menstrual Pelvic Pain responder threshold: at least 0.36 point decrease from baseline in Non-Menstrual Pelvic Pain score 
Trial 2 - Dysmenorrhea responder threshold: at least 0.85 point decrease from baseline in dysmenorrhea score; Non-Menstrual Pelvic Pain responder threshold: at least 0.43 point decrease from baseline in Non-Menstrual Pelvic Pain score*p ≤0.01 for test of difference from placebo;**p≤0.001 for test of difference from placebo

ORILISSA Prescribing Information
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.MORE INFO
**Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?**
The tables below summarize efficacy results by race and age.
**Table 3. Proportion of Responders at Month 3 (Primary) for Daily Assessment of Dysmenorrhea by Subgroups – Last Observation Carried Forward (Trial 1)**
ORILISSA 150 mg 
            once daily
            ORILISSA 200 mg 
            twice daily
            PlaceboN
            %
            N
            %
            N
            %RaceWhite
            220
            47
            213
            78
            322
            20Non-White
            28
            43
            31
            65
            51
            20Age (Years)32
            41
            39
            80
            51
            20≥ 25 to ≤ 35
            156
            46
            145
            74
            218
            16>35
            60
            50
            60
            78
            104
            28
FDA Review
**Table 4. Proportion of Responders at Month 3 (Primary) for Daily Assessment of Non-menstrual Pelvic Pain by subgroups- Last Observation Carried Forward (Trial 1)**
ORILISSA 150 mg 
            once daily
            ORILISSA 200 mg 
            twice daily
            PlaceboN
            %
            N
            %
            N
            %RaceWhite
            220
            52
            213
            55
            322
            37Non-White
            28
            39
            31
            52
            51
            35Age (Years)32
            44
            39
            44
            51
            31≥ 25 to ≤ 35
            156
            55
            145
            55
            218
            34>35
            60
            43
            60
            62
            104
            43
FDA Review
**Table 5. Proportion of Responders at Month 3 (Primary) for Daily Assessment of Dysmenorrhea by Subgroups – Last Observation Carried Forward (Trial 2)**
ORILISSA 150 mg 
            once daily
            ORILISSA 200 mg 
            twice daily
            PlaceboN
            %
            N
            %
            N
            %RaceWhite
            196
            42
            203
            75
            317
            23Non-White
            25
            52
            22
            50
            36
            22Age (Years)25
            56
            26
            65
            40
            20≥ 25 to ≤ 35
            118
            45
            109
            71
            195
            22>35
            78
            37
            90
            77
            118
            25FDA Review
**Table 6. Proportion of Responders at Month 3 (Primary) for Daily Assessment of Non-menstrual Pelvic Pain by Subgroups – Last Observation Carried Forward (Trial 2)**
ORILISSA 150 mg 
            once daily
            ORILISSA 200 mg 
            twice daily
            PlaceboN
            %
            N
            %
            N
            %RaceWhite
            196
            50
            203
            58
            317
            36Non-White
            25
            48
            22
            59
            36
            39Age (Years)25
            60
            26
            50
            40
            38≥ 25 to ≤ 35
            118
            45
            109
            52
            195
            34>35
            78
            54
            90
            67
            118
            41
FDA Review

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.
MORE INFO
What are the possible side effects (results of trials used to assess safety)?
The table below summarizes adverse reactions in endometriosis patients with moderate to severe dysmenorrhea and pelvic pain not related to menses (safety population)./p>
**Table 7. Percentage of Patients in Trials 1 and 2 with Treatment-Emergent Adverse Reactions Occurring in at Least 5% of Patients (either ORILISSA Dose Group) and at a Greater Incidence than Placebo**
Treatment- Emergent Adverse Reactions
            ORILISSA
            150 mg 
            once daily
            N=475
            ORILISSA
            200 mg 
            twice daily
            N=477
            Placebo N=734%
            %
            %Hot flushes or night sweats
            24
            46
            9Headache
            17
            20
            12Nausea
            11
            16
            13Insomnia
            6
            9
            3Mood altered, mood swings
            6
            5
            3Amenorrhea
            4
            7Depressed mood, depression, depressive symptoms and/or tearfulness
            3
            6
            2Anxiety
            3
            5
            3Arthralgia
            3
            5
            3
ORILISSA Prescribing Information
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.MORE INFO
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
The tables below summarize the occurrence of the most common adverse reactions by subgroup.
**Table 8. Pooled Subgroup Analysis of Hot Flushes (safety population)**
Demographic Characteristic
            ORILISSA 150 mg 
            once daily
            n/N (%)
            ORILISSA 200 mg
            twice daily
            n/N (%)
            Placebo
            n/N (%)RaceWhite
            98/419 (23)
            193/422 (46)
            57/645 (9)Black or African American
            11/44 (25)
            16/42 (38)
            2/62 (3)Asian
            1/4 (25)
            1/3 (33)
            1/9 (11)American Indian/ Alaska Native
            0/4 (0)
            0/0 (0)
            0/4 (0)Native Hawaiian or Other Pacific
            0/1 (0)
            1/2 (50)
            1/3 (33)Other
            1/3 (33)
            3/8 (38)
            2/11 (2)Age Group78/315 (25)
            131/312 (42)
            40/471 (9)> 35 years
            33/160 (21)
            83/165 (50)
            23/263 (9)
Clinical Trial Data
**Table 9. Pooled Subgroup Analysis of Headache (safety population)**
Demographic Characteristic
            ORILISSA 150 mg once daily
            n/N (%)
            ORILISSA 200 mg once daily
            n/N (%)
            Placebo
            n/N (%)RaceWhite
            69/419 (17)
            89/422 (21)
            81/645 (13)Black or African American
            9/44 (21)
            6/42 (14)
            6/62 (10)Asian
            1/4 (25)
            0/3 (0)
            2/9 (22)American Indian/ Alaska Native
            1/4 (25)
            0/0 (0)
            0/4 (0)Native Hawaiian or Other Pacific
            0/1 (0)
            1/2 (50)
            1/3 (33)Other
            0/3 (0)
            2/8 (25)
            0/11 (0)Age Group53/315 (17)
            61/312 (20)
            43/471 (9)> 35 years
            27/160 (17)
            37/165 (22)
            47/263 (18)
Clinical Trial Data
**Table 10. Pooled Subgroup Analysis of Nausea (safety population)**
Demographic Characteristic
            ORILISSA 150 mg once daily
            n/N (%)
            ORILISSA 200 mg twice daily
            n/N (%)
            Placebo
            n/N (%)RaceWhite
            47/419 (11)
            69/422 (16)
            77/645 (12)Black or African American
            3/44 (7)
            6/42 (14)
            11/62 (18)Asian
            0/4 (0)
            1/3 (33)
            1/9 (11)American Indian/ Alaska Native
            1/4 (25)
            0/0 (0)
            1/4 (25)Native Hawaiian or Other Pacific
            0/1 (0)
            0/2 (0)
            0/3 (0)Other
            0/3 (0)
            2/8 (25)
            4/11 (36)Age Group42/315 (13)
            50/312 (16)
            60/471 (9)> 35 years
            9/160 (6)
            28/165 (17)
            34/263 (9)
Clinical Trial Data
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**
**Pie chart summarizing how many women were in the clinical trial. In total, 1686 (100%) women participated in the clinical trials.**
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**
**Pie chart summarizing the percentage of patients by race enrolled in the clinical trials. In total, 1486 (88%) White, 148 (9%) Black or African American, 16 (1%) Asian, and 36 (2%) Other patients participated in the clinical trials.**
FDA Review
**Table 1. Demographics of Trials by Race**
Race
            Number of Patients
            Percentage of PatientsWhite
            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**
**Pie chart summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total, 1686patients (100%) were 18 to 49 years old.**
FDA Review
MORE INFO
Who participated in the trials?
The table below summarizes demographics of all patients in the combined clinical trials.
**Table 11. Demographic Characteristics for Trials 1 and 2**
Demographic Characteristics
            ORILISSA
            150 mg
            once daily
            N=475
            ORILISSA
            200 mg
            twice daily
            N=477
            Placebo
            N=734
            Total
            N=1686SexMale
            0
            0
            0
            0Female
            475 (100.0)
            477 (100.0)
            734 (100.0)
            1686 (100.0)RaceWhite
            419 (88.2)
            422 (88.5)
            645 (87.9)
            1486 (88.1)Black or African American
            44 (9.3)
            42 (8.8)
            62 (8.4)
            148 (8.8)Asian
            4 (0.8)
            3 (0.6)
            9 (1.2)
            16 (0.9)American Indian or Alaska Native
            4 (0.8)
            0
            4 (0.5)
            8 (0.5)Native Hawaiian or Other Pacific
            1 (0.2)
            2 (0.4)
            3 (0.4)
            6 (0.4)Other
            3 (0.6)
            8 (1.7)
            11 (1.5)
            22 (1.3)AgeMean (SD)
            32 + 6
            32 + 7
            32 + 7
            32 + 7Age Group18 to 25 years
            58 (12.2)
            66 (13.8)
            95 (12.9)
            219 (13.0)25 to 29 years
            104 (21.9)
            106 (22.2)
            164 (22.3)
            374 (22.1)30 to 34 years
            153 (32.2)
            140 (29.4)
            212 (28.9)
            505 (30.0)35 to 39 years
            91 (19.2)
            86 (18.0)
            143 (19.5)
            320 (19.0)40 to 49 years
            69 (14.5)
            79 (16.6)
            120 (16.3)
            268 (15.9)EthnicityHispanic or Latino
            68 (14.3)
            73 (15.3)
            107 (14.6)
            248 (14.7)Non-Hispanic
            407 (85.7)
            404 (84.7)
            627 (85.4)
            1438 (85.3)RegionUnited States
            355 (74.7)
            358 (75.1)
            548 (74.7)
            1261 (74.8)Non-United States
            120 (25.3)
            119 (24.9)
            186 (25.3)
            425 (25.2)
Clinical Trial Data
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.
MORE INFO
How were the trials designed?
The efficacy and safety of ORILISSA were established in 2 randomized, double-blind, placebo-controlled trials. Trials 1 and 2 evaluated ORILISSA for the treatment of moderate to severe pain associated with endometriosis. Patients were randomized to receive ORILISSA 150 mg once daily, ORILISSA 200 mg twice daily, or placebo for 6 months. The co-primary efficacy endpoints were the proportion of responders for dysmenorrhea and non-menstrual pelvic pain over a 3-month treatment period.
Dysmenorrhea and non-menstrual pelvic pain were evaluated using the Endometriosis Daily Pain Impact Scale. Patients rated their pain severity taking into account its impact on daily activities on a scale from 0 to 3, with higher scores reflecting more severe pain. Patients were considered responders if they had less dysmenorrhea and non-menstrual pelvic pain, and did not use more pain medication.
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
Back to Drug Trials Snapshots

                                                                                  Content current as of:
      08/13/2018Drug Approvals and Databases

          
                        


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