A critical review of oliceridine injection as an IV opioid analgesic for the management of severe acute pain

Figures & data

Figure 1. Analgesic efficacy: responder rates in the pivotal randomized controlled trials [18,19].

The primary endpoint analysis compared the percentage of treatment responders in each oliceridine regimen with the percentage of responders in the placebo regimen at 48 hours for the bunionectomy study and 24 hours for the abdominoplasty study. Responders were those who reached a ≥ 30% improvement in time-weighted sum of pain intensity differences (SPID) (at 48 hours for the bunionectomy study/24 hours for abdominoplasty study) from baseline while not receiving rescue pain medication, discontinuing study medication early, or reaching dosing limits. Figure Reproduced from Drugs of Today 2020, 56(4): 269. Copyright © 2020 Clarivate or its licensors. All rights reserved. DOI:10.1358/dot.2020.56.4.3107707

Table 1. Sum of pain intensity differences (SPID) from Phase 3 randomized placebo and morphine controlled studies: pre rescue scores carried forward 6 hours. Adapted from [18,19].

Orthopedic Surgery-Bunionectomy
SPID 48 Hours	Placebo N = 79	Oliceridine Demand Dose			Morphine
		0.1 mg N = 76	0.35 mg N = 76	0.5 mg N = 76	1 mg N = 76
Average	85	132	138	164	193
P-value vs placebo		<0.01	<0.01	<0.01	<0.01
Superiority vs placebo		Yes	Yes	Yes
Plastic Surgery-Abdominoplasty
		Oliceridine Demand Dose			Morphine
SPID 24 Hours	Placebo N = 79	0.1 mg N = 76	0.35 mg N = 76	0.5 mg N = 76	1 mg N = 76
Average	75	77	90	94	103
P-value vs placebo	-	0.75	0.017	<0.01	<0.01
Superiority vs placebo	-	No	Yes	Yes

Figure 2. Respiratory safety burden in pivotal Phase 3 studies of oliceridine [18,19]. RSB calculated as the mathematical product of the incidence of respiratory safety events and the mean duration of such events in affected patients. No statistically significant differences for any of the oliceridine treatment groups vs. morphine. Figure Reproduced from Drugs of Today 2020, 56(4): 269. Copyright © 2020 Clarivate or its licensors. All rights reserved. DOI:10.1358/dot.2020.56.4.3107707.

Table 2. Respiratory safety event measures in the pivotal Phase 3 studies. Adapted from [18,19].

Orthopedic Surgery (Bunionectomy) Study	Placebo (N = 79)	Oliceridine Regimens			Morphine 1 mg Regimen (N = 76)
		0.1 mg (N = 76)	0.35 mg (N = 79)	0.5 mg (N = 79)
Respiratory safety event measures
Oxygen saturation < 90%, n (%)	1 (1.3)	3 (3.9)	8 (10.1)	11 (13.9)	15 (19.7)
P value vs morphine	0.005	0.006	0.100	0.352	–
P value vs placebo	–	0.32	0.042	0.016	0.005
Respiratory rate ≤ 8 breaths/min, n (%)	0	0	1 (1.3)	1 (1.3)	4 (5.3)
P value vs morphine	0.956	0.956	0.188	0.185	–
P value vs placebo	–	1.0	0.961	0.961	0.956
Sedation (Moline-Roberts scale ≥3), n (%)	10 (2.7)	14 (18.4)	16 (20.3)	13 (16.5)	15 (19.7)
P value vs morphine	0.242	0.838	0.926	0.610	–
P value vs placebo	–	0.331	0.205	0.501	0.242
Plastic Surgery (Abdominoplasty) Study	Placebo (N = 83)	Oliceridine Regimens			Morphine 1 mg Regimen (N = 82)
		0.1 mg (N = 77)	0.35 mg (N = 79)	0.5 mg (N = 80)
Respiratory safety event measures
Oxygen saturation < 90%, n (%)	7 (8.4)	6 (7.8)	15 (19.0)	16 (20.0)	20 (24.4)
P value vs morphine	0.02	0.01	0.57	0.76	–
P value vs placebo	–	0.86	0.06	0.04	0.02
Respiratory rate ≤ 8 breaths/min, n (%)	1 (1.2)	0	4 (5.1)	6 (7.5)	8 (9.8)
P value vs morphine	0.054	0.95	0.38	0.84	–
P value vs placebo	–	0.96	0.18	0.07	0.054
Sedation (Moline-Roberts scale ≥3), n (%)	15 (18.1)	8 (10.4)	19 (24.1)	18 (22.5)	21 (25.6)
P value vs morphine	0.25	0.02	0.83	0.65	–
P value vs placebo	–	0.17	0.35	0.49	0.25

Singla NK, Skobieranda F, Soergel DG, et al., APOLLO-2: a randomized, placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the mu-opioid receptor, for management of moderate to severe acute pain following abdominoplasty. Pain Pract. 2019;19(7):715–731.

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Viscusi ER, Skobieranda F, Soergel DG, et al. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019;12:927–943.

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