ALISO VIEJO, Calif.
March 26, 2014
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered™ investigational drug-device combination product for the acute treatment of migraine.
As previously reported the company's 505(b)(2) NDA for AVP-825 includes data from one pivotal phase III clinical trial for the acute treatment of migraine. The NDA is also supported by data from a phase II placebo-controlled clinical trial for acute treatment of migraine, and two pharmacokinetic studies. Overall, the NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from the extensive clinical use of sumatriptan over the past 20 years.
The acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) V goal date is
November 26, 2014
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.