Rizaport (film formulation of rizatriptan)is approvable in Europe via decentralised procedure to treat migraine- RedHill Biopharma + IntelGenx
The German Federal Institute for Drugs and Medical Devices (BfArM) has confirmed the positive outcome of the European Decentralized Procedure and informed RedHill and IntelGenx that the European Marketing Authorization Application (MAA) for Rizaport (RHB-103) is approvable. RedHill and IntelGenx plan to submit the final required documentation to the BfArM and to the Luxembourg regulatory authority next week, which is expected to lead to marketing approval of Rizaport in both countries, and will continue their close cooperation in order to obtain national phase approvals in other Decentralized Procedure (DCP) European territories.
Comment: Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.�s Maxalt. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The administration method of the Rizaport oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative as many migraine patients, including those who suffer from migraine-related nausea - approximately 80% of the total migraine patient population.
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