IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine.
The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.
Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film. It dissolves rapidly releasing the active ingredient in the mouth, meaning there is no requirement for the patient to swallow a pill. This route of administration makes it a potential alternative, especially for migraine patients who suffer from migraine-related nausea.
Rizafilm’s active ingredient is rizatriptan – a serotonin (5-hydroxytryptamine or 5-HT) receptor agonist. The drug constricts blood vessels leading to a reduction in swelling and inflammation of blood vessels associated with migraine.
Migraine affects approximately 39 million people in the US and one billion people worldwide. According to GlobalData, the global migraine market will be worth $18.6bn by 2030.
IntelGenx’s president and CFO Andre Godin said that following successful pre-approval inspection of the company’s Montreal manufacturing facility by the FDA, the company is excited to soon introduce the first oral thin film for the treatment of acute migraines in the US.
Godin added: “We are looking forward to working with our commercialisation 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 approximately 80% of patients who have migraine-related nausea, as well as those who have difficulty swallowing.”