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Objective  The objective of this study was to compare the efficacy, tolerability, and safety of  AVP ‐825, an investigational bi‐directional breath‐powered intranasal delivery system containing low‐dose (22 mg) sumatriptan powder, vs 100 mg oral sumatriptan for acute treatment of migraine in a double‐dummy, randomized comparative efficacy clinical trial allowing treatment across multiple migraine attacks.    Background  In phases 2 and 3, randomized, placebo‐controlled trials,  AVP ‐825 provided early and sustained relief of moderate or severe migraine headache in adults, with a low incidence of triptan‐related adverse effects.    Methods  This was a randomized, active‐comparator, double‐dummy, cross‐over, multi‐attack study ( COMPASS ;  NCT 01667679) with two ≤12‐week double‐blind periods. Subjects experiencing 2‐8 migraines/month in the past year were randomized 1:1 using computer‐generated sequences to  AVP ‐825 plus oral placebo tablet or an identical placebo delivery system plus 100 mg oral sumatriptan tablet for the first period; patients switched treatment for the second period in this controlled comparative design. Subjects treated ≤5 qualifying migraines per period within 1 hour of onset, even if pain was mild. The primary end‐point was the mean value of the summed pain intensity differences through 30 minutes post‐dose ( SPID ‐30) using  H eadache  S everity scores. Secondary outcomes included pain relief, pain freedom, pain reduction, consistency of response across multiple migraines, migraine‐associated symptoms, and atypical sensations. Safety was also assessed.    Results  A total of 275 adults were randomized, 174 (63.3%) completed the study (ie, completed the second treatment period), and 185 (67.3%) treated at least one migraine in both periods (1531 migraines assessed). There was significantly greater reduction in migraine pain intensity with  AVP ‐825 vs oral sumatriptan in the first 30 minutes post‐dose (least squares mean  SPID ‐30 = 10.80 vs 7.41, adjusted mean difference 3.39 [95% confidence interval 1.76, 5.01];  P  < .001). At each time point measured between 15 and 90 minutes, significantly greater rates of pain relief and pain freedom occurred with  AVP ‐825 treatment compared with oral sumatriptan. At 2 hours, rates of pain relief and pain freedom became comparable; rates of sustained pain relief and sustained pain freedom from 2 to 48 hours remained comparable. Nasal discomfort and abnormal taste were more common with  AVP ‐825 vs oral sumatriptan (16% vs 1% and 26% vs 4%, respectively), but ∼90% were mild, leading to only one discontinuation. Atypical sensation rates were significantly lower with  AVP ‐825 than with conventional higher dose 100 mg oral sumatriptan.    Conclusions   AVP ‐825 (containing 22 mg sumatriptan nasal powder) provided statistically significantly greater reduction of migraine pain intensity over the first 30 minutes following treatment, and greater rates of pain relief and pain freedom within 15 minutes, compared with 100 mg oral sumatriptan. Sustained pain relief and pain freedom through 24 and 48 hours was achieved in a similar percentage of attacks for both treatments, despite substantially lower total systemic drug exposure with AVP‐825. Treatment was well tolerated, with statistically significantly fewer atypical sensations with  AVP ‐825.

headache: the journal of head and face pain

AVP ‐825 Breath‐Powered Intranasal Delivery System Containing 22 mg Sumatriptan Powder vs 100 mg Oral Sumatriptan in the Acute Treatment of Migraines (The  COMPASS  Study): A Comparative Randomized Clinical Trial Across Multiple Attacks