In a 275-patient Phase 3b clinical trial, Avanir Pharmaceuticals' (AVNR +1.7%) investigational migraine drug-device combination AVP-825 met its primary efficacy endpoint of achieving greater pain relief 30 minutes post dose compared to a 100 mg sumatriptan tablet. Several additional secondary endpoints were also met.
AVP-825 is a combination of low-dose sumatriptan powder (22 mg) delivered intranasally via a plastic handheld apparatus (corporate presentation, Slide 13). The user exhales into the device which propels the medication into one side of the nose where it is absorbed deep in the nasal cavity. The potential to swallow or inhale sumatriptan powder is minimized by the automatic closing of the soft palate when exhaling into the device.