Lipton RB, et al. - The physicians conducted this study to compare trajectories of migraine pain and disability over time for AVP-825 versus 100 mg oral sumatriptan tablets. Treatment with AVP-825 was correlated with faster reductions in migraine pain intensity and migraine-related disability starting at 10 minutes postdose and continuing through the first 30 minutes for migraine pain intensity and the first 45 minutes for migraine-related disability compared with 100 mg oral sumatriptan, resulting in lower overall pain intensity and disability that lasted through the first 2 h following treatment. Both migraine pain intensity and disability varied substantially both across subjects and within subjects across attacks.

• The data was used from the COMPASS study, a double-blind, double-dummy, active-comparator, cross-over study of people with a diagnosis of migraine.
• During the first of two 12-week treatment periods, participants treated up to 5 qualifying migraine attacks within 1 hour of onset with either AVP-825 plus placebo tablets or 100 mg oral sumatriptan tablets plus placebo delivery system.
• And, then switched treatment sequences to treat up to 5 more attacks in the second treatment period.
• Before dosing (predose), and at 10, 15, 30, 45, 60, 90 and 120 minutes, patients recorded ordinal migraine pain intensity and migraine-related disability.
• The physicians accounted 3-level ordinal multilevel models for unique data structure (repeated measures nested within attacks for each patient) and tested for treatment differences in migraine pain and migraine-related disability through the first 2 hours of attacks post dose.

• The physicians found significant between and within person variability in migraine pain intensity and migraine-related disability among 259 study participants (mean age 40.0 years, 84.6% female, 78.4% white).
• When treating with AVP-825 compared with oral sumatriptan, a typical individual demonstrated significantly faster reductions in migraine pain over the first 30 minutes and migraine-related disability over the first 45 minutes.
• Over 2 h following treatment, overall levels of pain and disability also favored AVP-825.
• With OR <1 indicating reduced pain/disability in the AVP-825 condition, model-based odds ratios (OR) comparing AVP-825 to oral sumatriptan ranged from 0.38 to 0.76 for pain and 0.37 to 0.65 for disability.