BioCentury
ARTICLE | Company News

Complete response for RedHill's RHB-103

February 5, 2014 2:06 AM UTC

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) received a complete response letter from FDA for an NDA for RHB-103 to treat acute migraines. According to RedHill and partner IntelGenx Corp. (TSX-V:IGX; OTCQX:IGXT), no additional clinical studies are needed. The partners said FDA raised questions related to third-party CMC, packaging and labeling for RHB-103. The companies plan to submit a response to FDA "within a few weeks." RedHill has exclusive, worldwide rights to co-develop and commercialize RHB-103 -- a fast-dissolving thin-film formulation of rizatriptan delivered using IntelGenx's VersaFilm oral disintegrating film -- from IntelGenx under a 2010 deal. ...