Avanir Pharma Achieves Primary Endpoint In Phase IIIb COMPASS Trial- Quick Facts

(RTTNews) - Avanir Pharmaceuticals, Inc. (AVNR) said its Phase IIIb clinical study evaluating the efficacy and safety of the investigational product AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults, met its primary 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.

The trial was a multicenter, randomized, double-blind, double-dummy crossover study in which migraine sufferers were treated with either 22 mg AVP-825 and placebo tablet or breath powered device-delivered placebo and 100 mg sumatriptan tablets.

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 AVP-825 compared with 100 mg sumatriptan tablet. Also, 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.

Joao Siffert, chief medical officer of Avanir commented: "These data show that AVP-825, an investigational product, can efficiently deliver sumatriptan and confers faster migraine headache relief at a lower dose than the most commonly utilized sumatriptan tablets."

The company intends to review the detailed data from the COMPASS study and present the full results at an upcoming medical meeting.