IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.
RIZAPORT offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily those who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water and pleasant flavor.
The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT under the European Decentralized Procedure.
RIZAPORT was previously approved for marketing in Germany. A first commercialization agreement for RIZAPORT was signed with Grupo JUSTE, now Exeltis Healthcare, for Spain. A second commercialization agreement for RIZAPORT was recently signed with Pharmatronic for South Korea.
RedHill and IntelGenx expect to re-submit the RIZAPORT 505(b)(2) NDA to the FDA in the third quarter this year. The companies also are continuing discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.