Avanir Licenses North American Rights to OptiNose’s NDA-Ready Drug-Device Combination for Migraine

Heather Cartwright
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Abstract

Avanir Pharmaceuticals has licensed North American rights to OptiNose’s Breath Powered™ intranasal delivery system containing low-dose sumatriptan powder for the treatment of acute migraine. The two companies will collaborate to complete the remaining activities needed to support regulatory submission of the drug-device combination, now known as AVP-825, with NDA filing expected by early 2014. If approved, AVP-825 will diversify Avanir’s CNS product portfolio beyond Nuedexta® (dextromethorphan plus quinidine sulphate), which is indicated for the treatment of pseudobulbar affect.
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Avanir获得OptiNose治疗偏头痛的NDA-Ready药物装置组合的北美权利
Avanir Pharmaceuticals已获得OptiNose的Breath Powered™鼻内给药系统的北美权利,该系统含有低剂量舒马曲坦粉末,用于治疗急性偏头痛。两家公司将合作完成所需的剩余活动,以支持药物器械组合的监管提交,现在称为AVP-825,预计将于2014年初提交NDA申请。如果获得批准,AVP-825将使Avanir的CNS产品组合在Nuedexta®(右美沙芬加硫酸奎尼丁)之外更加多样化,Nuedexta®用于治疗假性球的影响。
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