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.
A first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and additional potential territories. RedHill also recently entered in to a commercialization agreement with Pharmatronic Co. for S. Korea.
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. Re-submission of the RIZAPORT® U.S. NDA to the FDA is expected in the first half of 2017.