Table 2.
Respiratory safety parameters from pooled phase III controlled studies
| Safety parameter | Oliceridine demand dose (mg) | Placebo (n = 162) | Morphine 1 mg (n = 158) | ||
|---|---|---|---|---|---|
| 0.1 (n = 153) | 0.35 (n = 158) | 0.5 (n = 159) | |||
| Respiratory Safety Burdena (h) mean (SD) | 0.23 (1.1) | 0.88 (2.9) | 1.2 (3.8) | 0.3 (2.0) | 1.4 (3.5) |
| Respiratory Safety Eventb [n (%)] | 7 (4.6) | 24 (15.2) | 29 (18.2) | 5 (3.1) | 36 (22.8) |
| Duration of RSE (h) mean (SD) | 5.1 (2.0) | 5.8 (5.1) | 6.6 (6.8) | 9.9 (7.0) | 6.2 (4.9) |
| O2 saturation < 90% [n (%)] | 9 (5.9) | 23 (14.6) | 27 (17.1) | 8 (4.9) | 35 (22.2) |
| Respiratory rate ≤ 8 bpm | 0 | 5 (3.2) | 7 (4.4) | 1 (0.6) | 12 (7.6) |
| Dosing interruption due to RSE [n (%)] | 5 (3.2) | 22 (13.9) | 24 (15.1) | 3 (1.9) | 34 (21.5) |
| Patients receiving supplemental O2 [n (%)] | 7 (4.6) | 23 (14.6) | 28 (17.6) | 5 (3.1) | 36 (22.8) |
| Discontinuation for respiratory AE [n (%)] | 0 | 4 (2.5) | 7 (4.4) | 1 (0.6) | 5 (3.2) |
SD standard deviation, bpm beats per minute, AE adverse event
aRespiratory safety burden experienced by patients was calculated as the mathematical product of the incidence of a defined set of observed respiratory safety events (RSEs) multiplied by the mean expected cumulative duration of these events (in hours)
bMonitoring of RSE included concurrent assessment of continuous O2 saturation, stopwatch-timed respiratory rate for a full minute, and completion of the Moline Roberts Pharmacologic Sedation Scale (MRPSS)