RedHill Biopharma, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, together with IntelGenx Corp, a Canadian drug delivery company focused on oral drug delivery, announced the commencement of a comparative bioavailability clinical study comparing RHB-103 to the European reference drug.

The study is intended to support the planned submission of a European Marketing Authorization Application (MAA) for RHB-103, a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.

The comparative bioavailability study follows a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM) announced by RedHill in November 2013. This single-dose, crossover, comparative bioavailability study includes 26 healthy volunteers and is intended to evaluate and compare the relative bioavailability and to assess the bioequivalence of RHB-103 and the reference drug, Maxalt lingua, marketed in Germany by MSD SHARP & DOHME GMBH.

Results of the bioavailability study are anticipated by June 2014. Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with RHB-103, RedHill and IntelGenx plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure (MRP).

RedHill and IntelGenx previously conducted a successful bioavailability study which demonstrated the required US Food and Drug Administration (FDA) criteria for therapeutic bioequivalence between the RHB-103 soluble oral thin film and the US reference drug, Maxalt-MLT. Following the successful bioequivalence study, RedHill and IntelGenx announced in 2013 the submission to the FDA and acceptance for review of a New Drug Application (NDA) seeking marketing approval of RHB-103. Following a Complete Response Letter (CRL) received from the FDA in February 2014, which raised questions primarily related to Chemistry, Manufacturing and Controls (CMC), RedHill and IntelGenx recently reported that they believe that FDA approval of the RHB-103 NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.