FDA approves Rizafilm VersaFilm, an orally disintegrating film formulation for the acute treatment of migraine

This newly approved treatment is an orally disintegrating film formulation of the 5-HT1 receptor agonist designed to be bioequivalent to Merck’s Maxalt-MLT, an orally disintegrating rizatriptan treatment.

The treatment's bioequivalence was established in a single-dose, randomized, open-label, 3-way crossover, pivotal, comparative bioavailability study of Rizafilm 10 mg, Maxalt-MLT 10-mg orally disintegrating tablets, and Maxalt-Lingua 10-mg orodispersible tablets in 30 healthy volunteers. The study was conducted under the direction of Biopharma Services in Toronto, Ontario, Canada. The equivalence was announced in late 2018 by IntelGenx. The study was designed to determine whether the product is safe and bioequivalent to a leading anti-migraine product as measured by industry-standard pharmacokinetic measures, peak plasma concentration (Cmax), and area under the curve (AUC). The study results indicated that the product was safe and that the 90% confidence intervals of the 3 parameters of Cmax, AUC(0-t), and AUC(0-infinity) were well within the acceptable 80 to 125 range for bioequivalency.

Genesco has the exclusive right to market Rizafilm VersaFilm in the USA.