Table 5.
Nasal effects assessment parameters in randomized patients during Part B*
| Parameter | IN Benzhydrocodone/APAP | IN Hydrocodone/APAP | P† |
|---|---|---|---|
| (N = 44) | (N = 43) | ||
| Mean Emax (SD) | Mean Emax (SD) | ||
| Average | 1.5 (0.8) | 0.9 (0.8) | <0.0001 |
| Nasal burning | 1.6 (1.0) | 0.7 (0.7) | <0.0001 |
| Facial pain/pressure | 1.0 (1.0) | 0.5 (0.8) | <0.0001 |
| Need to blow nose | 1.5 (0.9) | 1.0 (0.9) | <0.0001 |
| Nasal irritation | 1.5 (1.0) | 0.7 (0.7) | <0.0001 |
| Nasal congestion | 1.5 (1.0) | 1.0 (0.8) | 0.0009 |
| Runny nose/nasal discharge | 1.4 (1.0) | 0.8 (0.9) | <0.0001 |
APAP = acetaminophen; Emax = maximum effect rating; IN = intranasal; LS = least squares.
*
Nasal effects were determined using a four-point Likert scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
†
Statistically significant difference in LS means for the comparison of IN benzhydrocodone/APAP vs IN hydrocodone/APAP.