Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. (NASDAQ:XNPT) today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

The data supporting safety and efficacy in the NDA filing comes from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan and the RLS clinical program conducted by XenoPort in the United States. The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort.

“We are pleased to submit the NDA for ASP8825 in Japan,” said Masafumi Nogimori, Astellas’ president and chief executive officer. “We look forward to delivering this new treatment to patients suffering from RLS in Japan.”

“Astellas has made great progress in advancing its RLS development program,” said Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer. “If approved, ASP8825 could be an important new treatment for patients with RLS in Japan.”