Table 2.
Other Secondary Efficacy Outcomes at Each Post-Dose Time Point
| Pre-dose | 10 minutes | 15 minutes | 30 minutes | 45 minutes | 1 hour | 1.5 hours | 2 hours | |
|---|---|---|---|---|---|---|---|---|
| Pain reduction, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 11.5 | 26.4 | 49.0 | 60.7 | 67.2 | 74.6 | 78.0 | |
| Oral sumatriptan (n = 766 attacks) | 10.2 | 19.6 | 35.2 | 49.9 | 59.8 | 69.8 | 75.2 | |
| OR (95% CI) | 1.16 (0.85, 1.60) | 1.51 (1.20, 1.90) | 1.79 (1.45, 2.21) | 1.56 (1.24, 1.96) | 1.37 (1.10, 1.71) | 1.26 (0.99, 1.61) | 1.15 (0.89, 1.49) | |
| P value | .35 | <.001 | <.001 | <.001 | .006 | .07 | .29 | |
| Pain freedom, percentage of mild attacks | ||||||||
| AVP-825 (n = 256 attacks) | 4.7 | 14.1 | 29.3 | 43.8 | 51.6 | 63.7 | 69.9 | |
| Oral sumatriptan (n = 234 attacks) | 3.4 | 9.4 | 17.9 | 29.9 | 41.5 | 57.3 | 66.2 | |
| OR (95% CI) | 1.45 (0.51, 4.09) | 1.59 (0.94, 2.69) | 1.87 (1.33, 2.64) | 1.70 (1.18, 2.46) | 1.45 (1.00, 2.11) | 1.35 (0.90, 2.04) | 1.13 (0.74, 1.70) | |
| P value | .48 | .08 | <.001 | .005 | .05 | .15 | .58 | |
| Pain freedom, percentage of moderate/severe attacks | ||||||||
| AVP-825 (n = 509 attacks) | 1.4 | 3.7 | 12.6 | 24.6 | 36.0 | 47.3 | 55.6 | |
| Oral sumatriptan (n = 532 attacks) | 0.4 | 1.1 | 7.7 | 17.5 | 29.1 | 39.5 | 51.9 | |
| OR (95% CI) | 3.65 (0.62, 21.38) | 3.83 (1.12, 13.11) | 1.76 (1.05, 2.95) | 1.58 (1.14, 2.18) | 1.37 (1.05, 1.81) | 1.40 (1.07, 1.84) | 1.16 (0.88, 1.53) | |
| P value | .15 | .03 | .03 | .006 | .02 | .02 | .30 | |
| Nausea, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 33.5 | 30.1 | 26.1 | 20.9 | 17.5 | 14.1 | 11.1 | 10.6 |
| Oral sumatriptan (n = 766 attacks) | 33.8 | 30.0 | 27.2 | 25.3 | 22.6 | 19.2 | 15.1 | 11.9 |
| OR (95% CI) | 1.01 (0.85, 1.20) | 0.99 (0.73, 1.36) | 0.89 (0.69, 1.15) | 0.73 (0.56, 0.96) | 0.68 (0.51, 0.91) | 0.66 (0.49, 0.89) | 0.67 (0.47, 0.94) | 0.85 (0.60, 1.20) |
| P value | .92 | .97 | .37 | .02 | .009 | .006 | .02 | .35 |
| Photophobia, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 74.2 | 68.8 | 63.9 | 52.0 | 45.0 | 37.3 | 32.2 | 25.4 |
| Oral sumatriptan (n = 766 attacks) | 78.6 | 74.9 | 72.8 | 64.0 | 56.7 | 46.5 | 37.2 | 30.3 |
| OR (95% CI) | 0.82 (0.67, 1.01) | 0.66 (0.48, 0.90) | 0.55 (0.41, 0.74) | 0.58 (0.45, 0.74) | 0.64 (0.51, 0.80) | 0.74 (0.60, 0.91) | 0.86 (0.67, 1.09) | 0.84 (0.65, 1.08) |
| P value | .06 | .01 | <.001 | <.001 | <.001 | .005 | .21 | .16 |
| Phonophobia, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 60.5 | 57.0 | 53.1 | 44.1 | 35.8 | 29.8 | 25.9 | 21.3 |
| Oral sumatriptan (n = 766 attacks) | 63.4 | 61.2 | 59.0 | 51.3 | 44.3 | 37.7 | 30.8 | 25.1 |
| OR (95% CI) | 0.91 (0.77, 1.07) | 0.72 (0.52, 1.00) | 0.65 (0.51, 0.84) | 0.68 (0.55, 0.84) | 0.67 (0.54, 0.82) | 0.69 (0.55, 0.87) | 0.82 (0.63, 1.06) | 0.85 (0.65, 1.12) |
| P value | .25 | .05 | <.001 | <.001 | <.001 | .002 | .12 | .25 |
| Vomiting, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 3.3 | 3.5 | 1.6 | 1.7 | 1.2 | 1.4 | 1.2 | 1.0 |
| Oral sumatriptan (n = 766 attacks) | 2.6 | 2.2 | 1.2 | 1.3 | 1.3 | 1.3 | 0.9 | 1.6 |
| OR (95% CI) | 1.47 (0.89, 2.43) | 1.38 (0.69, 2.78) | 2.14 (0.49, 9.31) | 1.37 (0.50, 3.77) | 0.94 (0.35, 2.50) | 1.10 (0.38, 3.20) | 0.84 (0.20, 3.50) | 0.46 (0.12, 1.77) |
| P value | .13 | .36 | .31 | .54 | .90 | .86 | .81 | .26 |
| Meaningful pain relief, percentage of attacks | ||||||||
| AVP-825 (n = 765 attacks) | 14.0 | 25.1 | 47.8 | 61.6 | 69.5 | 77.8 | 82.2 | |
| Oral sumatriptan (n = 766 attacks) | 7.4 | 16.2 | 34.7 | 49.3 | 60.7 | 72.7 | 79.5 | |
| OR (95% CI) | 2.13 (1.45, 3.11) | 1.74 (1.35, 2.25) | 1.75 (1.40, 2.20) | 1.65 (1.32, 2.06) | 1.49 (1.17, 1.90) | 1.29 (1.00, 1.66) | 1.15 (0.88, 1.50) | |
| P value | <.001 | <.001 | <.001 | <.001 | .001 | .05 | .31 | |
| Clinical Disability Scale, least squares mean change from pre-dose (SE) | ||||||||
| AVP-825 (n = 185 patients) | −0.08 (0.017) | −0.18 (0.025) | −0.42 (0.038) | −0.60 (0.046) | −0.73 (0.049) | −0.83 (0.052) | −0.92 (0.054) | |
| Oral sumatriptan (n = 185 patients) | −0.03 (0.017) | −0.09 (0.025) | −0.26 (0.038) | −0.43 (0.046) | −0.56 (0.049) | −0.72 (0.052) | −0.85 (0.054) | |
| Adjusted mean difference (95% CI) | −0.04 (−0.08, −0.01) | −0.09 (−0.14, −0.04) | −0.16 (−0.23, −0.09) | −0.17 (−0.25, −0.08) | −0.16 (−0.26, −0.07) | −0.11 (−0.21, −0.02) | −0.07 (−0.17, 0.03) | |
| P value | .02 | <.001 | <.001 | <.001 | <.001 | .02 | .17 | |
OR are based on the fitted generalized estimating equations models.
CI = confidence interval; OR = odds ratio; SE = standard error.