FDA Approves Film Formulation of Migraine Drug

The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for a film formulation of rizatriptan benzoate (Rizafilm VersaFilm; IntelGenx Corp, Saint-Laurent, Quebec, Canada) for the treatment of acute migraine. Rizafilm VersaFilm is a serotonin (5-HT) 1B/1D receptor agonist (triptan) 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. The therapy is a proprietary oral thin film formulation of the drug (10 mg rizatriptan) administered on the tongue.  

The most common adverse reactions reported in adults were (incidence ≥ 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea. IntelGenx Corp reports that it has entered into a licensing, development, and supply agreement with Gensco Pharma for the exclusive commercialization of Rizafilm VersaFilm in the United States. 

“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 CFO, IntelGenx Corp. “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.”