AVP 825 filed with the FDA for Migraine-OptiNose
A New Drug Application (NDA) has been submitted to the FDA for AVP 825 (sumatriptan), from OptiNose, which uses a closed-palate Breath Powered intranasal delivery system to deliver low-doseage powder for the acute treatment of Migraine. The submission is based on a series of studies conducted by OptiNose in the US and Europe, including comparative bioavailability and Phase II and Phase III TARGET trial efficacy studies in patients with Migraine.
OptiNose's closed-palate Breath Powered delivery technology is unique in that it uses the natural function of a user's breath to propel medications beyond the nasal valve into the deep, targeted areas of the nasal cavity more effectively and efficiently than current treatment approaches.
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