RedHill Biopharma and IntelGenx announced that it has submitted a New Drug Application (NDA) to the FDA seeking marketing approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan, a drug for the treatment of acute migraine. RHB-103 is an oral thin film formulation of rizatriptan benzoate (Maxalt, Maxalt-MLT; Merck), a 5-HT1 agonist. RHB-103 is based on proprietary VersaFilmTM technology.
This submission was based on a successful bioequivalence clinical trial demonstrating the required FDA criteria for therapeutic equivalence between RHB-103 and Maxalt MLT.
In the fourth quarter this year, RedHill plans to submit a second NDA for the marketing approval of RHB-102, a patent protected, oral, extended release formulation of ondansetron for the prevention of nausea and vomiting in cancer patients. This submission will be based off a successful bioavailability trial and a recent meeting with the FDA.