FDA Agrees to Review Drug–Device Combo for Migraine
Approval decision expected in November
The FDA has accepted a new drug application (NDA) for AVP-825, an investigational drug–device combination product for the acute treatment of migraine.
The Prescription Drug User Fee Act (PDUFA) goal date is November 26, 2014.
The NDA submission included data from a pivotal phase III trial, as well as findings from a phase II placebo-controlled study and two pharmacokinetic studies. Overall, the NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and refers to data from the extensive clinical use of sumatriptan over the past 20 years.
AVP-825 is an investigational drug–device combination product consisting of low-dose sumatriptan powder delivered intranasally via “Breath Powered” delivery technology. If approved, AVP-825 would be the first fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
The Breath Powered delivery technology is activated by the user’s breath to propel medications deep into the nasal cavity, where absorption is more efficient and consistent than through most other routes, according to the product’s developer (Avanir Pharmaceuticals).
The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. 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 expanded, and the 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.
Source: Avanir Pharmaceuticals; March 26, 2014.