RizaFilm FDA Approval History

Last updated by Judith Stewart, BPharm on April 18, 2023.

FDA Approved: Yes (First approved April 14, 2023)
Brand name: RizaFilm
Generic name: rizatriptan
Dosage form: Oral Film
Company: IntelGenx Corp.
Treatment for: Migraine

RizaFilm (rizatriptan) is a serotonin (5-HT) 1B/1D receptor agonist (triptan) oral film formulation for the acute treatment of migraine.

• RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 12 to 17 years of age weighing 40 kg or more.
• Migraine is a type of headache characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head. Rizatriptan works to treat migraine by binding to 5-HT_1B/1D receptors to inhibit dural vasodilation and inflammation.
• Rizatriptan was first approved in an oral tablet formulation under the brand name Maxalt in 1998.
• RizaFilm oral film is administered on the tongue. The oral film disintegrates in about 2 minutes and can then be swallowed. No liquid is required. Adults may take a second dose at least 2 hours after the first dose if needed, but no more than three oral films can be taken in a 24 hour period.
• Warnings and precautions associated with RizaFilm include myocardial ischemia, myocardial infarction, and Prinzmetal's angina; arrhythmias; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; gastrointestinal ischemic events, peripheral vasospastic reactions; hypersensitivity reactions; medication overuse headache; and serotonin syndrome.
• The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea.

Development timeline for RizaFilm

Further information

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