Phase III COMPASS trial of OptiNose Bi-Directional System(sumatriptan) shows benefits in pain relief-Avanir Pharma

Avanir Pharmaceuticals has announced that COMPASS, its Phase IIIb, cross-over clinical trial comparing the efficacy and safety of OptiNose Bi-Directional System, known as AVP 825 (sumatriptan drug delivery system) for the treatment of acute migraine across multiple attacks, has been published at the 57th Annual Scientific Meeting of the American Headache Society. 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. These data show that AVP 825 can help migraine sufferers achieve fast pain relief across more migraine attacks, at a substantially lower dose, compared with the most commonly prescribed triptan 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.

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.

Comment: AVP 825 will have generic sumapriptan to compete against. While 42% of patients treated with AVP-825 in the TARGET trial felt pain relief within 30 minutes of dosing, it is estimated that about 30% of patients treated with sumitriptan nasal spray experienced pain relief within 30 minutes in prior clinical trials. The difference may not be enough to differentiate the OptiNose product.