OBJECTIVES: Migraine-associated symptoms—nausea, photophobia and/or phonophobia—can contribute to disability and direct healthcare costs. The composite efficacy endpoint, total migraine freedom (TMF), is more rigorous than other pain endpoints and assesses pain freedom and absence of migraine-associated symptoms, providing a more comprehensive understanding of treatment impact than evaluation of items individually. TMF was assessed for AVP-825, an investigational Breath Powered intranasal delivery system containing 22mg sumatriptan powder, vs 100mg oral sumatriptan (oral-SUM) in the COMPASS study (NCT01667679). METHODS: Multicenter, double-dummy, crossover, multi-attack study with two 12-week double-blind periods. Patients (2–8 attacks/month) were randomized to AVP-825 plus oral placebo or an identical placebo delivery system plus 100mg oral-SUM (period-1); treatment switched for period-2. Patients treated ≤5 qualifying migraines/period (<1 hour from onset, even if mild). Percentage of attacks with TMF (pain freedom and absence of migraine-associated symptoms, including vomiting) at timepoints from 10 minutes–2 hours post-dose was calculated post hoc and analyzed by chi-square test. RESULTS: