Neuron

Avanir Pharmaceuticals has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for approval of its new breath-powered investigational drug-device combination product ‘AVP-825’ for the acute treatment of migraines.

The NDA includes data from one Phase III clinical study for the acute treatment of migraine, and is also supported by data from a Phase II placebo-controlled clinical trial for acute treatment of migraine and two pharmacokinetic studies.

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The NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from extensive clinical use of sumatriptan over the last 20 years.

Avanir chief scientific officer Joao Siffert said the AVP-825 NDA submission represents an important milestone for the company.

"The NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from extensive clinical use of sumatriptan over the last 20 years."

"If approved by the FDA, AVP-825 could meet a key unmet need by providing patients with a unique device that efficiently delivers a low dose of sumatriptan powder, providing rapid relief of migraine headache, coupled with good tolerability," Siffert said.

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 migraine.

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AVP-825 is an investigational drug-device combination product that includes low-dose sumatriptan powder delivered intranasally using a new breath-powered delivery technology, which 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.

The company licensed exclusive rights for the development and commercialisation of AVP-825, a novel breath-powered intranasal system containing a low-dose sumatriptan powder, from OptiNose.

Image: AVP-825 provides rapid relief of migraines. Photo: courtesy of freedigitalphotos.net.