RIZAPORT® (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 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 held in November 2012 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.

In October 2014 RedHill and IntelGenx submitted a Marketing Authorization Application (MAA) to the German Federal Institute for Drugs and Medical Devices (BfArM) seeking European marketing approval of RIZAPORT® under the European Mutual Recognition Procedure (MRP). The submission is supported by several studies, including a successful bioavailability study which established the bioequivalence of RHB-103 and the European reference drug, Maxalt® lingua, and followed a  a positive European Scientific Advice meeting with the German BfArM.