RIZAPORT（利扎曲坦口服薄膜剂：以前RHB-103）是一种快速治疗偏头痛的治疗制剂

2015年11月9日，RHB-103（利扎曲普坦口服膜剂）在德国全球首次获得批准，由RedHill和IntelGenx共同开发，商品名RIZAPORT，用于治疗急性偏头痛。
RIZAPORT™ (Migraine/rizatriptan/RHB-103)
RIZAPORT™ (formerly RHB-103) is a proprietary oral fast dissolving thin film formulation of rizatriptan for the treatment of migraine.
RIZAPORT™ is being co-developed with Montreal-based IntelGenx Corp. following an August 2010 RedHill-IntelGenx co-development agreement. RIZAPORT™ is planned to be indicated for the treatment of acute migraines.
In November 2015 RedHill and IntelGenx announced that Germany's BfArM granted marketing authorization of RIZAPORT™ (RHB-103) 5mg and 10mg. The national approval of RIZAPORT™ in Germany was granted under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. This authorization is the first national marketing approval of RIZAPORT™. Marketing authorization in Luxemburg, the Concerned Member State, is expected to follow.
In March 2013, RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA seeking marketing approval of RIZAPORT™, following a positive Pre-NDA meeting with the FDA and a successful bioequivalence study. The pivotal bioequivalence clinical trial demonstrated the bioequivalence between RedHill’s oral thin-film RIZAPORT™ and Merck & Co.’s Maxalt-MLT®.
In February 2014 RedHill and IntelGenx announced that they received a Complete Response Letter (CRL) from the FDA regarding the RIZAPORT™ NDA. The FDA letter raised no questions or deficiencies relating to RIZAPORT™’s safety and bio-equivalence data, and did not require additional clinical trials. The questions raised by the FDA primarily relate to third party CMC and to the packaging and labeling of the product. RedHill and IntelGenx submitted a response to the FDA in March 2014 – FDA’s review of the RIZAPORT™ NDA continues.