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news.The German Federal Institute for Drugs and Medical Devices (BfArM) has granted marketing authorization for Rizaport (RHB-103) to treat acute migraines.
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Rizaport, 5 mg and 10 mg, is an oral thin film formulation of rizatriptan benzoate. It is being developed by RedHill Biopharma and IntelGenx.
It is the first oral thin film bioequivalent to Merck’s Maxalt Lingua.
Rizaport is a therapeutic option for patients suffering from dysphagia (difficulty swallowing) and those suffering from migraine-related nausea, which may be 80% of the entire migraine population.
More than 50 million people in Europe are projected to be affected by migraines and about 2 million Europeans are prone to daily migraine attacks.
BfArM granted the national approval for Rizaport under the European Decentralized Procedure (DCP) in which Germany was the reference member state.
Clearance in Luxembourg, the concerned member state, is expected to take place shortly. The companies plan to work together to secure approvals in other European DCP territories.
IntelGenx president and CEO Horst Zerbe said: "We are committed to bringing Rizaport to market as soon as possible, as we believe it will be a potentially beneficial treatment for patients suffering from migraines."
RedHill Biopharma and IntelGenx submitted a New Drug Application (NDA) to the US Food and Drug Administration in 2013.
A complete response letter was received from the FDA in 2014 citing issues related to chemistry, manufacturing and controls. The companies are working to address the concerns, including a compliant source of raw material.
Image: Migraine is a neurological disease characterized by moderate to severe headaches in association with several autonomic nervous system symptoms. Photo: courtesy of renjith krishnan/FreeDigitalPhotos.net.