A randomized, Phase IIb study investigating oliceridine (TRV130), a novel µ-receptor G-protein pathway selective (μ-GPS) modulator, for the management of moderate to severe acute pain following abdominoplasty

Figures & data

Table 1 Demographic and baseline characteristics

Characteristic	Placebo (n=39)	Oliceridine		Morphine regimen (n=83)
		Regimen A (n=39)	Regimen B (n=39)
Age (years)	37.4 (9.2)	37.2 (7.9)	40.3 (12.0)	37.5 (9.1)
Sex, female, n (%)	37 (95%)	39 (100%)	39 (100%)	83 (100%)
Race, n (%)
American Indian or Alaska native	2 (5%)	0	0	1 (1%)
Asian	0	0	1 (3%)	3 (4%)
Black/African American	20 (51%)	12 (31%)	18 (46%)	32 (39%)
Native Hawaiian/Pacific Islander	0	0	2 (5%)	1 (1%)
White	17 (44%)	27 (69%)	18 (46%)	45 (54%)
Other	0	0	0	1 (1%)
Ethnicity, n (%)
Hispanic or Latino	10 (26%)	15 (39%)	16 (41%)	30 (36%)
Weight (kg)	72.6 (11.3)	70.8 (10.8)	68.4 (8.4)	72.0 (11.0)
BMI (kg/m^2)	26.5 (3.2)	27.2 (3.1)	26.1 (2.5)	26.9 (3.1)
Baseline pain (NPRS)	7.6 (1.3)	8.3 (1.2)	7.4 (1.5)	7.5 (1.3)

Notes: Data are mean (SD) unless otherwise specified. Loading/demand doses (mg/mg): oliceridine regimen A, 1.5/0.10; oliceridine regimen B, 1.5/0.35; morphine, 4.0/1.0.

Abbreviations: BMI, body mass index; NPRS, numeric pain rating scale; SD, standard deviation.

Figure 1 Changes from baseline (±SE) in TWA NPRS from 0 to 24 hours by treatment group.

Notes: Loading/patient-controlled demand doses (mg/mg): oliceridine regimen A, 1.5/0.10; oliceridine regimen B, 1.5/0.35; morphine, 4.0/1.0. P=0.0001, oliceridine regimen A versus placebo; P=0.0005, oliceridine regimen B versus placebo; P<0.0001, morphine versus placebo.
Abbreviations: SE, standard error; TWA, time-weighted average; NPRS, numeric pain rating scale.

Figure 2 Least square mean change from baseline in TWA NPRS, 5 minutes after second loading dose, by treatment group.

Notes: Loading/patient-controlled demand doses (mg/mg): oliceridine regimen A, 1.5/0.10; oliceridine regimen B, 1.5/0.35; morphine, 4.0/1.0. ^*P<0.05 versus placebo; ^$P<0.05 versus morphine (least square mean difference).
Abbreviations: TWA, time-weighted average; NPRS, numeric pain rating scale.

Figure 3 Median time to onset of meaningful pain relief by treatment group.

Notes: Loading/patient-controlled demand doses (mg/mg): oliceridine regimen A, 1.5/0.10; oliceridine regimen B, 1.5/0.35; morphine, 4.0/1.0.

Table 2 TEAEs in ≥10% of patients

	Placebo (n=39)	Oliceridine		Morphine regimen (n=83)
		Regimen A (n=39)	Regimen B (n=39)
TEAEs in ≥10% of patients
Patients with ≥1 TEAE	24 (62%) [48]	26 (67%) [54]	32 (82%) [67]	78 (94%) [238]
Gastrointestinal disorders
Nausea	7 (18%) [7]	16 (41%) [17]	18 (46%) [18]	60 (72%) [63]
Vomiting	3 (8%) [3]	6 (15%) [6]	6 (15%) [6]	35 (42%) [35]
Nervous system disorders
Headache	5 (13%) [5]	6 (15%) [6]	6 (15%) [6]	14 (17%) [14]
Dizziness	1 (3%) [1]	1 (3%) [1]	4 (10%) [4]	7 (8%) [7]
Somnolence	0	0	2 (5%) [2]	10 (12%) [10]
Vascular disorders
Hypotension	1 (3%) [1]	6 (15%) [6]	3 (8%) [3]	7 (8%) [7]
Phlebitis	4 (10%) [4]	0	2 (5%) [2]	1 (1%) [2]
Respiratory, thoracic, and mediastinal disorders
Hypoventilation	4 (10%) [5]	4 (10%) [4]	12 (31%) [12]	34 (41%) [34]
Respiratory depression	0 (0) [0]	3 (8%) [3]	0 (0) [0]	9 (11%) [10]

Notes: Data are number of patients (%) [number of events]. Loading/demand doses (mg/mg): oliceridine regimen A, 1.5/0.10; oliceridine regimen B, 1.5/0.35; morphine, 4.0/1.0.

Abbreviation: TEAE, treatment-emergent adverse event.

Figure S1 Patient disposition.

Figure S2 Least squares mean change from baseline in TWA NPRS from (A) 0–4 hours, (B) 0–8 hours, (C) 0–12 hours, and (D) 0–24 hours with placebo and morphine by study stage.

Note: Loading/patient-controlled demand doses (mg/mg): morphine, 4.0/1.0.

Abbreviations: TWA, time-weighted average; NPRS, numeric pain rating scale.