Avanir Reports Publication Of Positive Phase IIIb Results From AVP-825 Study

(RTTNews) - Avanir Pharmaceuticals, Inc. (AVNR) announced that COMPASS, its Phase IIIb, cross-over clinical trial comparing the efficacy and safety of AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraine across multiple attacks, has been published and is available in hard copy at the 57th Annual Scientific Meeting of the American Headache Society or AHS in Washington, DC.

AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered™ delivery technology. A New Drug Application (NDA) for AVP-825 has been accepted and is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of November 6, 2015.

The study results showed that patients treated with AVP-825 achieved pain relief and pain freedom in significantly more migraine attacks at all time points from 15-90 minutes post-dose compared to sumatriptan tablets. AVP-825 and sumatriptan tablets achieved sustained pain relief and pain freedom at 24 and 48 hours in a similar number of attacks.

In addition, AVP-825 treated patients experienced early resolution of all migraine-associated symptoms of nausea, sensitivity to sound and to light in more attacks compared with sumatriptan tablets.

The overall safety profile of AVP-825 was consistent with that observed in previous trials. There were no serious adverse events during the study. Nasal discomfort and product taste were the most commonly reported adverse events, occurring more frequently in the AVP-825 treatment group. Nearly 90% of these reported adverse events were deemed mild and led to only one patient discontinuing treatment. Atypical sensations, sometimes called "triptan effects" were significantly less frequent among patients treated with AVP-825 compared with sumatriptan tablets (2% and 5%, respectively; p=0.02).