The Food and Drug Administration (FDA) has approved RizaFilm® (rizatriptan) oral film for the treatment of acute migraine with or without aura in adults and pediatric patients 12 to 17 years of age weighing 40kg or more.
RizaFilm is an orally dissolving film formulation of rizatriptan, a serotonin (5-HT) 1B/1D receptor agonist. The oral film is placed on the tongue, where it disintegrates within approximately 2 minutes and can be swallowed with saliva. Administration with liquid is not necessary.
The approval was based on data from a relative bioavailability study comparing RizaFilm 10mg oral film to rizatriptan benzoate 10mg tablets. The application, which was submitted through the FDA’s 505(b)(2) regulatory pathway, contains clinical safety and efficacy data from the reference listed drug, rizatriptan benzoate tablet. The most common adverse reactions reported with RizaFilm were asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea.
RizaFilm oral film is supplied in a carton containing 6-, 12-, or 18-individually packaged films; each oral film contains 10mg of rizatriptan benzoate.
“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,” said Andre Godin, IntelGenx’s President and CFO. “In addition to these benefits, Rizafilm® is well suited to the approximately 80% of patients who have migraine-related nausea, as well as those who have difficulty swallowing.”
- IntelGenx announces FDA approval of Rizafilm® for the treatment of acute migraine. News release. IntelGenx. Accessed April 17, 2023. https://www.globenewswire.com/news-release/2023/04/17/2647913/0/en/IntelGenx-Announces-FDA-Approval-of-RIZAFILM-for-the-Treatment-of-Acute-Migraine.html.
- RizaFilm. Package insert. IntelGenx; 2023. Accessed April 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s000lbl.pdf.