XenoPort has planned to file a new drug application (NDA) in Japan for XP13512 (ASP8825), as a potential treatment for moderate-to-severe primary restless legs syndrome (RLS), in the second half of 2009 fiscal year.
Reportedly, the evidence of efficacy for the NDA filing will be based on data from Astellas’ successful phase 2 study in RLS patients conducted in Japan, and XenoPort’s clinical program conducted in the US.
Ronald Barrett, CEO of XenoPort, said: “With no approved drugs in Japan for the treatment of RLS, we are pleased that Astellas is pursuing what is known as a bridging strategy to potentially accelerate the availability of a treatment for RLS patients in Japan.
“We are working diligently with Astellas to permit them to move aggressively to file the NDA in Japan by the end of March 2010. We thank our Astellas colleagues for their creative development strategy on this project,” he added.