RedHill Biopharma Ltd. (Nasdaq:RDHL; TASE: RDHL) today announced that together with IntelGenx Corp., it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine.
Redhill is focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs.
The NDA was submitted under a 505(b)(2) regulatory path, following a positive pre-NDA meeting with the FDA and is supported by a successful bioequivalence clinical trial that demonstrated the required FDA criteria for therapeutic equivalence between the soluble oral film of RHB-103 and Merck & Co.’s Maxalt MLT.
RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1 agonist and the active drug in Merck & Co.’s Maxalt drugs. Rizatriptan is considered one of the most effective oral triptans - a class of molecules that constrict blood vessels in the brain in order to relieve swelling and other migraine symptoms. The worldwide market of triptans was estimated at $2.1 billion in 2011, of which the worldwide direct sales of Merck & Co.’s rizatriptan-based drugs exceeded $600 million.
RHB-103 is based on IntelGenx's proprietary “VersaFilm” technology. The RHB-103 thin film strip dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream.
RedHill product manager Elkan Gamzu said, "RedHill’s RHB-103 oral thin film is characterized by rapid dissolution, ease of use, pleasant flavoring, and the ability to administer without water, all of which we believe are important for patients who suffer from migraines."
Last month RedHill reported that it plans submitting a second NDA in the fourth quarter of 2013, for US marketing approval of RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron for the prevention of nausea and vomiting in cancer patients. The RHB-102 planned NDA submission follows a successful bioavailability trial, as well as a recent Type B meeting with the FDA.
Published by Globes [online], Israel business news - www.globes-online.com - on March 27, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013