The company had previously announced a successful a pre-NDA meeting with the FDA following the successful completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT(R), a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt(R) were $638 million in 2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (RDHL) (RDHL) using IntelGenx' proprietary immediate release "VersaFilm(TM)" drug delivery technology.
IntelGenx' orally disintegrating film consists of a thin (30 -- 50 um) polymeric film which disintegrates rapidly upon oral administration, thereby releasing the active drug Rizatriptan and making it available for rapid absorption. The film does not require water for administration.