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New Drug Application Submitted for Migraine Treatment
Intranasal delivery system uses sumatriptan powder (January 30)
A new drug application (NDA) has been submitted to the FDA for AVP-825 (OptiNose US, Inc./Avanir Pharmaceuticals), a product that uses the Breath Powered intranasal delivery system to deliver low-dose sumatriptan powder for the acute treatment of migraine.
The NDA submission is based on results from laboratory and clinical studies conducted in the U.S. and Europe, including comparative bioavailability and phase II and phase III efficacy studies, in patients with migraine.
When the Breath Powered delivery system is used, the exhaled breath carries medication from the device into one side of the nose through a sealing nosepiece. Narrow nasal passages are expanded, and the medication is transported beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air flows around to the opposite side of the nasal cavity and exits through the other side of the nose rather than into the throat or lungs.
If approved, AVP-825 would be the first fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
Source: OptiNose US, Inc.; January 30, 2014.