FDA Accepts NDA for Novel Intranasal Sumatriptan to Treat Migraines


Exciting news was disseminated from Avanir Pharmaceuticals’ on March 28, 2014 with their announcement that the FDA had accepted a New Drug Application for their intranasal form of Sumatriptan. Designed as a novel and investigational drug-device combination product coined AVP-825, this unique form of Sumatriptan is a breath powered, intranasal form of migraine treatment. The breath powered delivery is an innovative technology in which the user’s breath activates and propels the Sumatriptan dry powder into the nasal cavity. This method of administration is believed to be more effective as once the patient exhales into the device their soft palate automatically closes and seals off the nasal cavity, thus preventing unnecessary inhalation or swallowing of the Sumatriptan powder into their lungs. Once enveloped deep inside the nasal cavity this powder form of Sumatriptan is efficiently absorbed by the body, leading to faster and more effectual relief. This inventive AVP-825 device is constructed to deliver treatment with Sumatriptan on one side of the nasal passages via a nosepiece placed in the nostril. The ability of the nasal passages to expand quickly and rapidly absorb medications makes this new method ideal for fast acting relief for migraine sufferers.

Sumatriptan-CAS-103628-46-2

The NDA presented to the FDA for the AVP-825 Sumatriptan device is based on clinical data from a successful Phase II trial. The aforementioned trial, as well as two pharmokinetic studies, included 222 patients who sought treatment for acute migraine headaches. Reference data from two decades of clinical trial research based on the safety and viability of Sumatriptan was also presented in the NDA . With the pathophysiology of migraine headaches still not fully understood, a cure is essential for the estimated 36 million Americans who suffer from migraines. The World Health Organization has placed migraine headaches as one of the 20 most disabling medical illnesses worldwide. While most patients who suffer from these devastating headaches experience between one and four migraines a month, three percent of migraine headache sufferers have chronic migraines. These patients with chronic migraines experience excruciating and disabling headaches for at least fifteen days or more each month, for a period of six months or longer. Migraines are estimated to cost the U.S. over $20 billion every year from missed work, lost productivity, physician visits and medications.

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