Table 3.
First Key Secondary Endpoint: SPID48 Compared to HB/APAP
| Abdominoplasty | Bunionectomy | |||
|---|---|---|---|---|
| Suzetrigine N = 447 |
HB/APAP N = 448 |
Suzetrigine N = 426 |
HB/APAP N = 431 |
|
| Prespecified analysis with rescue imputation (imputed) | ||||
| LS mean ± SE | 118.4 ± 4.3 | 111.8 ± 4.3 | 99.9 ± 4.5 | 120.1 ± 4.5 |
| LS mean difference from HB/APAP | 6.6 | — | –20.2 | — |
| 95% CI | (–5.4 to 18.7) | — | (–32.7 to –7.7) | — |
| P value vs. HB/APAP | 0.2781 | — | 0.0016 | — |
| Post hoc analysis without rescue imputation (as treated) | ||||
| LS mean ± SE | 153.0 ± 4.5 | 141.0 ± 4.5 | 128.8 ± 4.7 | 140.6 ± 4.7 |
| LS mean difference from HB/APAP | 12.0 | — | –11.8 | — |
| 95% CI | (–0.5 to 24.4) | — | (–24.8 to 1.2) | — |
| Nominal P value vs. HB/APAP* | 0.0595 | — | 0.0752 | — |
Table includes participants who were randomized and received at least one dose of study drug. Participants were analyzed according to their randomized treatment.
Analyses for SPID48 compared to HB/APAP without rescue imputation are post hoc; therefore, P values are nominal.
HB/APAP, hydrocodone bitartrate/acetaminophen; LS mean, least squares mean; N, number of participants in the analysis set; SE, standard error; SPID48, time‑weighted sum of the pain intensity difference as recorded on the numeric pain rating scale from 0 to 48 h.