RHB-103

RHB-103 is a proprietary oral fast dissolving thin film formulation of rizatriptan for the treatment of migraine. RHB-103 is being co-developed with Montreal-based IntelGenx Corp. following an August 2010 RedHill-IntelGenx co-development agreement. RHB-103 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 RHB-103, following a positive Pre-NDA meeting with the FDA held in November 2012 and a successful bioequivalence study .
In February 2014 RedHill and IntelGenx announced that they received a Complete Response Letter (CRL) from the FDA regarding the RHB-103 NDA. The FDA letter raised no questions or deficiencies relating to RHB-103′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, addressing the issues raised in the CRL.

In November 2013, RedHill announced is had concluded a positive European Scientific Advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM). Following the positive meeting with the BfArM, RedHill plans to complete a bioavailability study and submit a Marketing Authorization Application (MAA) for marketing approval of RHB-103 in Europe during 2014, with Germany as the reference member state under the European Mutual Recognition Procedure (MRP).

 

In May 2012, RedHill announced positive results in a pivotal bioequivalence clinical trial demonstrating bioequivalence between RedHill’s oral thin-film RHB-103 and Merck & Co.’s Maxalt-MLT®.