AVP 825 meets primary endpoint in Phase III trial for Migraine - Avanir Pharma

Avanir Pharmaceuticals has announced that COMPASS, its Phase IIIb clinical trial of the efficacy and safety of AVP 825 (drug delivery system sumatriptan) for the treatment of acute Migraines in adults has met the primary efficacy endpoint. AVP 825, or the OptiNose Bi-Directional System, is a drug-device combination consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology. The COMPASS study met the primary endpoint for the sum of pain intensity difference at 30 minutes post dose, showing that Migraine sufferers achieved greater pain relief within 30 minutes of treatment with 22 mg of the investigational product AVP 825 compared with 100 mg sumatriptan tablet.

In addition, AVP 825 treated Migraine sufferers achieved pain freedom in a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes post dose compared with those treated with sumatriptan tablet. Several additional secondary endpoints relating to pain relief were also met. The overall safety profile was consistent with that observed in previous trials, with less than 2% of subjects experiencing an adverse event leading to treatment discontinuation. Avanir plans to review the detailed data from the COMPASS study and present the full results at an upcoming medical meeting. AVP 825 was filed for approval with the FDA in January 2014.