RedHill Biopharma Submits NDA for Oral Thin Film Drug
RedHill Biopharma Ltd. recently announced the company and its co-development partner, IntelGenx Corp., have submitted a New Drug Application (NDA) to the US
FDA seeking marketing approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine.
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 approximately $2.1 billion in 20111, of which the worldwide direct sales of Merck & Co.’s rizatriptan-based drugs exceeded $600 million.
RHB-103 is based on IntelGenx’ 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.
“We are very pleased with the submission of the NDA for RHB-103. It is our first NDA and an important milestone for RedHill and IntelGenx, as it brings us one step closer to making this attractive thin film rizatriptan drug available for migraine patients in need,” said Elkan Gamzu, RedHill’s RHB-103 Product Manager. “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.”
RedHill further reported on February 25, 2013, of its plan to submit a second NDA in the fourth quarter of 2013, for the 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.
RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs. For more information, visit www.redhillbio.com.
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. For more information, visit www.intelgenx.com.
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