ALISO VIEJO, Calif.
June 10, 2014
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that COMPASS, its Phase IIIb clinical trial comparing the efficacy and safety of the investigational product AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults, met the primary efficacy endpoint. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered™ delivery technology. In
, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) of AVP-825 and the Prescription Drug User Fee Act (PDUFA) V goal date is
November 26, 2014
The COMPASS study met the primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30), 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 (p<0.0001). 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 (p<0.05). In these topline data, several additional secondary endpoints relating to pain relief were also met.
The overall safety profile of AVP-825, an investigational product, was consistent with that observed in previous trials, with less than 2% of subjects experiencing an adverse event leading to treatment discontinuation. There were no serious adverse events in the study. Nasal discomfort and abnormal product taste were more common with AVP-825 administration; these adverse events were deemed mild in nearly 90% of cases.
Avanir plans to review the detailed data from the COMPASS study and present the full results at an upcoming medical meeting.