About the StudyThis randomized, single-dose, four-way cross-over study assessed the pharmacokinetic (PK) profile of AVP-825 (Breath Powered intranasal device delivering 22mg sumatriptan powder) to IMITREX ® (sumatriptan) subcutaneous injection (6 mg), liquid nasal spray (20 mg) and oral tablets (100 mg) in 20 healthy adult volunteers. Standard PK assessments including peak plasma concentration, drug exposure over time and total drug exposure were measured.
About AVP-825AVP-825 is an investigational drug-device combination product utilizing a novel Breath Powered intranasal technology to deliver a low-dose of sumatriptan powder. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan.
The 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 efficiently and consistently than current treatments. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. The exhaled breath carries medication from the device into one side of the nose through a sealing nosepiece. Narrow nasal passages are gently expanded and medication is transported well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air painlessly 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.
About Avanir Pharmaceuticals, Inc.Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries. IMITREX® is a registered trademark of GlaxoSmithKline. All other trademarks are the property of their respective owners. Avanir Pharmaceuticals licensed exclusive rights for the development and commercialization of AVP-825, a novel Breath Powered TM intranasal system containing a low-dose sumatriptan powder from OptiNose Inc. of Yardley, PA. ©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.