Avanir Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. AVP-825 consists of intranasally delivered low-dose sumatriptan powder, using a novel Breath Powered delivery technology.
The submission was based on data from one pivotal Phase 3 clinical trial for the acute treatment of migraine. The NDA is also supported by data from a Phase 2 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.
If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
For more information call (855) 468-3339 or visit Avanir.com.