IntelGenx’s (TSXV:IGX; OTCQX:IGXT) commercialization partner, Groupo Juste, which is now part of Exceltis Healthcare, has received national marketing authorization for RIZAPORT 10 mg from the Spanish Agency of Medicines and Medical Devices.
RIZAPORT is an oral thin film formulation of rizatriptan for the treatment of acute migraines. RIZAPORT offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water and neutral flavor.
Following approval of the manufacturing site transfer of RIZAPORT from the European contract manufacturer listed in the initial manufacturing site transfer application to IntelGenx’s GMP compliant facility in Montreal, the marketing authorization will enable Exceltis Healthcare to commercialize the product in Spain.
The company believes that recently reported results from a successful study, demonstrating that RIZAPORT is bioequivalent to the European reference drug, Maxalt-Lingua, will further support the site transfer application in Spain.
“This marketing authorization in Spain marks the achievement of a major milestone for our company, materially advancing RIZAPORT toward becoming the first-ever commercialized VersaFilm product to be manufactured at our new state-of-the-art facility,” Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement.
