Table 3.
Group comparisons | Mean difference in VAS Drug High score, mm* | Lower 95% CI | Upper 95% CI |
---|---|---|---|
Study ALO-01-07-205 (oral dosing) | |||
Placebo versus IRMS | 75.2 | 63.62 | 86.78 |
Placebo versus intact ALO-01 | 45.7 | 29.24 | 62.16 |
Placebo versus crushed ALO-01 | 39.8 | 21.98 | 57.62 |
Crushed versus intact ALO-01 | 5.6 | −3.54 | 24.74 |
IRMS versus intact ALO-01 | 29.8 | 16.27 | 43.33 |
IRMS versus crushed ALO-01 | 35.4 | 20.24 | 50.56 |
Study ALO-01-07-106 (IV dosing) | |||
Placebo versus MS | 85.20 | 79.33 | 91.07 |
Placebo versus MS + NTX | 29.80 | 17.73 | 41.87 |
MS versus MS + NTX | 55.40 | 41.98 | 68.82 |
VAS Drug High at Emax were the following: 29.8 mm for MS + NTX; 85.2 mm for MS alone; and 0.0 for placebo
ALO-01 extended-release morphine with sequestered naltrexone, CI confidence interval, IRMS immediate-release MS, MS morphine sulfate, NTX naltrexone, VAS visual analog scale