Avanir Submits AVP-825 NDA for Migraines
Avanir announced that it has submitted a New Drug Application (NDA) to the FDA for AVP-825, an investigational drug-device combination product for the acute treatment of migraines. AVP-825 consists of intranasally delivered low-dose sumatriptan powder, using a novel Breath Powered delivery technology.
The NDA submission is based on data from one pivotal Phase 3 clinical trial, a Phase 2 placebo-controlled trial, and two pharmacokinetic studies for the acute treatment of migraine. The submission includes safety data from 222 patients receiving AVP-285 in clinical trials and references data from the use of sumatriptan in clinical use from the past 20 years.
For more information call (949) 389-6700 or visit Avanir.com.