FDA Approves Rizatriptan Benzoate Oral Film to Treat Acute Migraine

The FDA has approved a new drug application for Rizafilm, an oral thin film formulation of rizatriptan benzoate, for the treatment of acute migraine.¹

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“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 US,” said Andre Godin, president and chief financial officer of IntelGenx, in a press release.¹

Current guidelines recommend triptans for the treatment of acute migraine in patients unlikely to respond to less effective therapies. Rizatriptan is a second-generation triptan that is rapidly absorbed from the gastrointestinal tract and achieves maximum plasma concentrations more quickly than other triptans, providing rapid migraine relief for patients, according to investigators.²

In clinical trials, rizatriptan has been shown to be at least as effective or superior to other oral migraine-specific agents for acute migraine and shows more consistent long-term efficacy across multiple migraine attacks. It has a favorable tolerability profile and patients have reported greater satisfaction and a preference for rizatriptan over other agents. In addition, improvements in quality of life reported with rizatriptan are consistent with its favorable efficacy and tolerability profiles.²

Importantly, multi-attribute decision models combining clinical data with patient- and physician-reported treatment preferences have identified rizatriptan as 1 of 3 triptans closest to a hypothetical “ideal” treatment. With all of these supporting data, the efficacy and tolerability of rizatriptan for acute migraine treatment has been well established.²

“According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide,” Godin said in the press release. “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. 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.”¹

REFERENCE

1. IntelGenx Announces FDA Approval of Rizafilm for the Treatment of Acute Migraine. News release. IntelGenx Corp; April 17, 2023. Accessed April 17, 2023. https://www.intelgenx.com/newsrooms/newsrooms1/128-2023-news/884-ntelenxnnouncespprovaloffortherea20230417.html
2. Lainez MJA. Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat 2;2006(3).