RizaFilm, a variant of the migraine medication rizatriptan that has been formed into a thin film that is absorbed in the mouth, has been authorized by the FDA.
IntelGenx, a Canadian business that specialized in such films, created the product. RizaFilm will be commercialized in the United States by GenscoPharma.
The active component in Merck & Co.’s Maxalt is rizatriptan.
“RizaFilm has a number of advantages that make it an appealing migraine treatment option.” It is also the most convenient triptan on the market. “It’s portable, and unlike tablets, it doesn’t require water,” Andre Godin, president and CFO of IntelGenx, told Formulary Watch.
According to IntelGenx, RizaFilm was created utilizing VersaFilm, the company’s patented oral film technology.
Maxalt MLT, an orally disintegrating tablet, has a complex packaging system and is difficult to transport, according to Godin.
“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.
The American Migraine Foundation estimates that 39 million Americans suffer from migraine.
The worldwide migraine medicines market was worth almost $3 billion in 2021 and is anticipated to be worth nearly $11 billion by 2030, representing a 15.6% compound annual growth rate.
RizaFilm, in addition to “providing quick relief for migraine sufferers’ pain,” is “well suited to the approximately 80% of patients who have migraine-related nausea, as well as those who have difficulty swallowing,” according to Godin.
IntelGenx, according to Godin, cannot predict on whether insurance and payers would 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, once RizaFilm is launched, there will be marketing and awareness activities, and we expect physicians to prescribe the product.” For the time being, RizaFilm is likewise protected from generic flicks. “It’s patent protected until July 2034, and our patent is listed in the Orange Book,” Godin explained.
In recent years, the FDA has authorized a number of film products, including Belbuca, a film version of buprenorphine used to treat chronic pain; Sympazan, a film version of clobazam, an antiseizure medicine; and Kynmobi, a film version of apomorphine used to treat Parkinson’s disease.
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