On announcing the news, IntelGenx' President and CEO Dr. Horst Zerbe commented, "We are very pleased with the FDA's confirmation that our anti-migraine film application has been accepted for review. We believe that our Rizatriptan film is the first oral film product for the treatment of migraine for which a 505(b)(2) NDA has been submitted to FDA. We consider that the product has significant market potential as it is therapeutically equivalent to Maxalt-MLT(R) orally disintegrating tablets, is easy to use, and offers significant cost advantages over orally disintegrating tablets."
IntelGenx had previously announced a successful pre-NDA meeting with the FDA following the 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. 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 (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.