Trial Outcomes & Findings for Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D) (NCT NCT04043455)

Last Updated: 2025-01-30

Results Overview

The APS is a single question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. The change in AAPS from Baseline at Week 12 was analyzed using a mixed-effects model repeated measures (MMRM) analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. An unstructured variance-covariance matrix was used for the MMRM analysis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

273 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2025-01-30

Participant Flow

This was a 2-treatment period study (12-week Main Study Double-Blind Treatment Period and 52-week Double-Blind Long-Term Extension \[LTE\] Treatment Period) to assess the efficacy, safety and tolerability of Olorinab in the treatment of abdominal pain in participants with irritable bowel syndrome (IBS), who were not on concomitant treatment for IBS.

A total of 273 participants were enrolled into the 12-week Main Study Period and a total of 105 participants continued into the 52-week LTE Period.

Participant milestones

Participant milestones
Measure	Main Study Period: Olorinab 10 mg Participants were randomized to receive Olorinab 10 mg 3 times per day (TID) for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	Main Study Period: Olorinab 25 mg Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Olorinab 50 mg Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	LTE Period: Olorinab 25 mg Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 25 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 25 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 25 mg dose for the LTE Period.	LTE Period: Olorinab 50 mg Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 50 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 50 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 50 mg dose for the LTE Period.
Main Study Double-Blind Treatment Period STARTED	67	67	69	70	0	0
Main Study Double-Blind Treatment Period Received Treatment	67	66	69	70	0	0
Main Study Double-Blind Treatment Period COMPLETED	59	53	61	58	0	0
Main Study Double-Blind Treatment Period NOT COMPLETED	8	14	8	12	0	0
Double-Blind LTE Treatment Period STARTED	0	0	0	0	53	52
Double-Blind LTE Treatment Period Received Treatment	0	0	0	0	53	51
Double-Blind LTE Treatment Period COMPLETED	0	0	0	0	0	0
Double-Blind LTE Treatment Period NOT COMPLETED	0	0	0	0	53	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study Period: Olorinab 10 mg Participants were randomized to receive Olorinab 10 mg 3 times per day (TID) for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	Main Study Period: Olorinab 25 mg Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Olorinab 50 mg Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	LTE Period: Olorinab 25 mg Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 25 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 25 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 25 mg dose for the LTE Period.	LTE Period: Olorinab 50 mg Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 50 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 50 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 50 mg dose for the LTE Period.
Main Study Double-Blind Treatment Period Adverse Event	2	3	2	3	0	0
Main Study Double-Blind Treatment Period Withdrawal by Subject	4	5	4	9	0	0
Main Study Double-Blind Treatment Period Physician Decision	0	2	1	0	0	0
Main Study Double-Blind Treatment Period Lost to Follow-up	1	2	1	0	0	0
Main Study Double-Blind Treatment Period Protocol Violation	0	1	0	0	0	0
Main Study Double-Blind Treatment Period Regional site closure order due to Covid 19	1	0	0	0	0	0
Main Study Double-Blind Treatment Period Did not receive treatment	0	1	0	0	0	0
Double-Blind LTE Treatment Period Adverse Event	0	0	0	0	0	2
Double-Blind LTE Treatment Period Withdrawal by Subject	0	0	0	0	5	6
Double-Blind LTE Treatment Period Lost to Follow-up	0	0	0	0	1	0
Double-Blind LTE Treatment Period Study termination by Sponsor	0	0	0	0	47	44

Baseline Characteristics

Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg 3 times per day (TID) for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	Main Study Period: Olorinab 25 mg n=67 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to receive the same dose in the LTE Period.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks. After completion of the Main Study, participants in this arm could continue to the LTE Period and were re-randomized to receive either 25 mg or 50 mg Olorinab.	Total n=273 Participants Total of all reporting groups
Age, Continuous	41.5 Years STANDARD_DEVIATION 11.47 • n=5 Participants	39.0 Years STANDARD_DEVIATION 12.68 • n=7 Participants	39.5 Years STANDARD_DEVIATION 12.98 • n=5 Participants	41.8 Years STANDARD_DEVIATION 14.38 • n=4 Participants	40.4 Years STANDARD_DEVIATION 12.92 • n=21 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	49 Participants n=7 Participants	50 Participants n=5 Participants	49 Participants n=4 Participants	197 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	76 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	22 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	65 Participants n=21 Participants
Race/Ethnicity, Customized Multiple races	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	46 Participants n=7 Participants	39 Participants n=5 Participants	50 Participants n=4 Participants	173 Participants n=21 Participants
Race/Ethnicity, Customized Not reported	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=49 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=46 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=55 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=52 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	-2.32 Scores on a scale Standard Error 0.293	-2.45 Scores on a scale Standard Error 0.297	-2.68 Scores on a scale Standard Error 0.285	-2.14 Scores on a scale Standard Error 0.289

PRIMARY outcome

Timeframe: Up to 14 Weeks

Population: Main Study Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=66 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Any TEAEs	34 Participants	33 Participants	31 Participants	35 Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 54 Weeks

Population: LTE Period Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment in the LTE Period.

An AE was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=53 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=51 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks.
LTE Period: Number of Participants With TEAEs and SAEs Any TEAEs	17 Participants	14 Participants	—	—
LTE Period: Number of Participants With TEAEs and SAEs Any SAEs	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Baseline to Week 14

Population: Main Study Safety Set.

Blood samples were collected for the analysis of laboratory parameters including serum chemistry, hematology, coagulation, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=66 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to Week 54 (of LTE)

Population: LTE Safety Set.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=53 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=51 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks.
LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline to Week 14

Population: Main Study Safety Set.

Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), heart rate (HR), body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=66 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to Week 54 (of LTE)

Population: LTE Safety Set.

Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), HR, body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=53 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=51 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks.
LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Main Study Full Analysis Set.

The percentage of participants achieving a \>= 30% improvement in AAPS from Baseline at Week 12 was analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by the stratification factors. Missing post-baseline AAPS data was imputed using multiple imputation (MI) under the missing at random (MAR) assumption. Participants who were randomized but did not have at least 1 post-Baseline observation were considered non-responders. A \>= 30% improvement in AAPS was a reduction in AAPS of 30% or more when compared to Baseline AAPS.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=67 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12	56.7 Percentage of participants Interval 44.85 to 68.58	59.7 Percentage of participants Interval 47.96 to 71.45	56.5 Percentage of participants Interval 44.82 to 68.22	52.9 Percentage of participants Interval 41.16 to 64.55

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Main Study Full Analysis Set.

The percentage of participants achieving a \>= 30% improvement in AAPS from Baseline for at least 6 of the 12 weeks during the Treatment Period were analyzed using a CMH test stratified by the stratification factors. A \>= 30% improvement in AAPS is a reduction in AAPS of 30% or more when compared to Baseline AAPS. Missing post-baseline AAPS data was imputed using MI under the MAR assumption.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=67 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=67 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=69 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=70 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks	53.7 Percentage of participants Interval 41.79 to 65.67	53.7 Percentage of participants Interval 41.79 to 65.67	53.6 Percentage of participants Interval 41.86 to 65.39	47.1 Percentage of participants Interval 35.45 to 58.84

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed.

The percent change in AAPS from Baseline at Week 12 was analyzed using an MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=49 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=46 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=55 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=52 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Percent Change From Baseline in AAPS at Week 12	-36.91 Percent change Standard Error 4.459	-37.73 Percent change Standard Error 4.521	-38.44 Percent change Standard Error 4.327	-34.48 Percent change Standard Error 4.388

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed.

The change from Baseline at Week 12 in number of pain-free days per week was analyzed using a MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline pain free days as a covariate. Pain-free days were defined as days with a pain score of zero (0). Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=49 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=46 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=55 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo n=52 Participants Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Change From Baseline in Number of Pain-Free Days at Week 12	0.61 Days per week Standard Error 0.218	0.39 Days per week Standard Error 0.222	0.66 Days per week Standard Error 0.213	0.54 Days per week Standard Error 0.216

SECONDARY outcome

Timeframe: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose

Population: Main Study PK Analysis Set comprises of all participants in the Full Analysis Set with at least one post-dose PK parameter. Only those participants with data available at the specified timepoints were analyzed.

Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Cmax of Olorinab. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=56 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=53 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=58 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Maximum Concentration (Cmax) of Olorinab Day 1	296.4 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51.48	591.2 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 57.16	963.7 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 107.4	—
Main Study: Maximum Concentration (Cmax) of Olorinab Week 4	320.5 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 123.4	361.7 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 350.4	1097 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 113.4	—

SECONDARY outcome

Timeframe: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose

Population: Main Study PK Analysis Set. Only those participants with data available at the specified timepoints were analyzed. Sampling times reflected timeframe based on actual time and not planned nominal time.

Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Tmax of Olorinab. PK analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Main Study Period: Olorinab 10 mg n=53 Participants Participants were randomized to receive Olorinab 10 mg TID for 12 Weeks.	Main Study Period: Olorinab 25 mg n=51 Participants Participants were randomized to receive Olorinab 25 mg TID for 12 Weeks.	Main Study Period: Olorinab 50 mg n=54 Participants Participants were randomized to receive Olorinab 50 mg TID for 12 Weeks.	Main Study Period: Placebo Participants were randomized to receive placebo TID for 12 Weeks.
Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab Day 1	1.00 Hours Interval 1.0 to 4.27	2.02 Hours Interval 0.5 to 4.15	1.02 Hours Interval 0.5 to 8.08	—
Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab Week 4	1.00 Hours Interval 0.0 to 2.25	1.00 Hours Interval 0.0 to 2.48	1.00 Hours Interval 0.0 to 2.05	—

SECONDARY outcome

Timeframe: Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12

Population: Main Study PK Analysis Set. Only those participants with data available at the specified timepoints were analyzed.

Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate Ctrough of Olorinab. PK analysis was conducted using standard non-compartmental methods.