FDA Clears Rizafilm to Treat Acute Migraine

The FDA has approved RizaFilm, a version of the migraine medicine rizatriptan that has been formulated into a thin film that gets absorbed in the mouth.

The product was developed by IntelGenx, a Canadian company that specializes in such films. GenscoPharma will commercialize RizaFilm in the U.S.

Rizatriptan is the active ingredient in Merck & Co.'s Maxalt.

“RizaFilm has a number of advantages that make it a compelling treatment option for migraine sufferers. It’s the fastest triptan on the market and is also convenient. It’s easy to carry and unlike a tablet, does not require water,” Andre Godin, president and CFO of IntelGenx, told Formulary Watch.

IntelGenx says RizaFilm was formulated using the VersaFilm, the compnay’s proprietary oral film technology.

Maxalt MLT, an orally disintegrating tablet, has an extensive packaging system and is cumbersome to carry, Godin 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.” Godin said.

According to the American Migraine Foundation, 39 million Americans suffer from migraine.

The global migraine drugs market was valued at nearly $3 billion in 2021 and is expected to reach nearly $11 billion by 2030 — a compound annual growth rate of 15.6%.

In addition to “providing quick relief for migraine sufferers’ pain,” RizaFilm is “well suited to the approximately 80% of patients who have migraine-related nausea, as well as those who have difficulty swallowing,” Godin said.

Godin said IntelGenx cannot speculate on whether insurers and payers will cover the treatment, but “we believe the advantages to patients of RizaFilm are clear and are hopeful that it will be covered.”

“As with all branded products, there will be marketing and awareness activities once RizaFilm is launched, and we expect physicians will prescribe the product. RizaFilm is also protected against generic films for the time being. It is patent protected until July 2034, with our patent listed in the Orange Book,” Godin said.

FDA has approved a number of film products the past several years including Belbuca, a film version of buprenorphine that is used to treat chronic pain; Sympazan a film version of clobazam, an antiseizure medication; and Kynmobi, a film version of apomorphine that is used to Parkinson’s disease.