Oral film to treat acute migraines to be launched across the US after FDA approval

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Migraine Drug delivery Drug delivery systems Pharmacology Food and drug administration NDA United states

A drug to treat acute migraines has been given approval for a new drug application (NDA) by the US Food and Drug Administration (FDA).

Pharmaceutical film producer, IntelGenx Corp, made the announcement on Monday (April 17) that Rizafilm is to be launched by its partner Gensco Pharma across the US as soon as is practicable.

The two companies entered a definitive licensing, development, and supply agreement back in December 2018 for exclusive commercialization of Rizafilm in the US, which had been previously approved in Europe under the name Rizaport.

A migraine is a headache that can cause pain so severe it interferes with daily activities and can last anything from a few hours to several days. The exact cause is not known but family history can increase risk. It’s characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head.

Women taking estrogen or a vasilodator (a drug that can improve blood flow through the arteries or veins by widening them) are at higher risk. Warning signs that start between 15 and 60 minutes before the headache can include blurred vision, temporary blind or bright spots, lines and hallucinations, unusual tiredness and tingling in an arm or leg.

At the onset of migraine, the trigeminal nerve releases a chemical called calcitonin gene-related peptide (CGRP) which relaxes the blood vessel walls causing vasodilation. Rizafilm works by binding to serotonin (5-hydroxytryptamine or 5-HT) receptors in the brain to reduce vasodilation and inflammation of the blood vessels associated with migraine.

It’s an oral film that disintegrates on the tongue contains the drug which belongs to the class of medicines called serotonin receptor agonists (triptans).

Andre Godin, IntelGenx’s president, said: “Following a successful pre-approval inspection by the FDA of our Montreal manufacturing facility earlier this month, we are thrilled to reach this milestone and excited to soon introduce what will be the first oral thin film for the treatment of acute migraines available in the U.S.

“According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide. We are looking forward to working with our commercialization partner, Gensco, to bring this innovative migraine therapeutic to patients seeking convenient administration and quick relief from their pain. In addition to these benefits, Rizafilm is well suited to the approximately 80% of patients who have migraine-related nausea3, as well as those who have difficulty swallowing.” 

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