The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals’ new drug application (NDA) of its breath-powered investigational drug-device combination product AVP-825 for the acute treatment of migraines.
Avanir’s 505(b)(2) NDA for AVP-825 includes data from one major Phase III clinical trial for the acute treatment of migraines.
The NDA is based on data from a placebo-controlled Phase II clinical trial for acute treatment of migraine, and two pharmacokinetic studies. It 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 and the Prescription Drug User Fee Act (PDUFA) V goal date is 26 November 2014.
AVP-825 consists of low-dose sumatriptan powder delivered intranasally using a new breath-powered delivery technology.
The company said that if approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraines.
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 compared to most other routes.
The soft palate and sealing off the nasal cavity automatically gets closed, when a user exhales into the device, and closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.
The exhaled breath carries medication from the device directly into one side of the nose via a sealing nosepiece placed into the nostril.
According to the company, narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed.
Avanir licensed exclusive rights for the development and commercialisation of AVP-825 from OptiNose.