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.” 

Related news

Show more

Related products

State-of-the-Art Virtual Pharma Factory Tour

State-of-the-Art Virtual Pharma Factory Tour

Content provided by METTLER TOLEDO | 09-Jun-2023 | Event Programme

Join METTLER TOLEDO’s weighing experts on a virtual tour of a state-of-the-art manufacturing facility. On the call, you'll be digitally transported...

The Right CDMO Can Unlock Faster Drug Development

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

A Guide Through the API Drug Development Pipeline.

A Guide Through the API Drug Development Pipeline.

Content provided by Lonza Small Molecules | 04-Apr-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Content provided by Lonza Small Molecules | 28-Mar-2023 | White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Related suppliers

Follow us


View more