VANCOUVER, BC—Treatment of acute migraine with AVP-825, an investigational Breath Powered Bi-Directional intranasal delivery system containing sumatriptan powder 22mg, resulted in higher rates of total migraine freedom at earlier time points than the most efficacious dose of oral sumatriptan 100mg “despite less drug exposure,” a study presented at the 68th AAN Annual Meeting has found.
“These results demonstrate the superiority of AVP-825 using a more rigorous migraine efficacy endpoint”—total migraine freedom—than that studied in the COMPASS trial, reported Rashmi Halker, MD, an assistant professor of neurology at the Mayo Clinic, Phoenix, AZ. However, “findings are consistent with the other outcomes of COMPASS, indicating AVP-825 has superior early efficacy compared to oral sumatriptan,” she added.
The Phase 3b COMPASS study compared the efficacy and safety of AVP-825 22mg with sumatriptan 100mg tablets for the treatment of acute migraines in adults.
As a composite efficacy endpoint, total migraine freedom is more rigorous than other pain endpoints. By assessing pain freedom and absence of migraine-associated symptoms—such as nausea, photophobia, and/or phonophobia, which can contribute to disability and direct healthcare costs—a “more comprehensive understanding of treatment impact than evaluation of items individually” can be attained.
In the multicenter, double-dummy, crossover study with two 12-week double-blind periods, patients with 2–8 migraine attacks per month were randomly assigned 1:1 to AVP-825 plus oral placebo or an identical placebo delivery system (containing lactose) plus oral sumatriptan 100mg for the first period; for the second period, the treatments were switched.
Patients were instructed to treat up to and including 5 qualifying migraines per period within 1 hour of onset, even if mild. The percentage of attacks with total migraine freedom at time points from 10 minutes to 2 hours post-dose was calculated and analyzed by the chi-square test.
A total of 185 patients completed both periods, yielding 1,531 migraines treated and assessed, 765 with AVP-825 and 766 with oral sumatriptan.
The percentage of attacks with total migraine freedom was found to be significantly greater with AVP-825 vs. oral sumatriptan at all time points from 15–90 minutes. At 15 minutes, it was 7.2% for AVP-825 vs. 3.7% for oral sumatriptan (P<0.01); 30 minutes, 18.0% vs. 10.8% (P<0.001); 45 minutes, 30.7% vs. 21.4% (P<0.001); 60 minutes, 40.9% vs. 33.3% (P<0.01); and 90 minutes, 52.7% vs. 45.6% (P<0.01), respectively.
At 2 hours, rates of total migraine freedom did not differ significantly between treatments, 60.7% for AVP-825 compared with 56.7% for oral sumatriptan (P=0.11).
AVP-825 (Onzetra XSail; Avanir) was approved by the Food and Drug Administration (FDA) on January 28, 2016 for the treatment of migraine with or without aura in adults.