Astellas and XenoPort Announce Approval of Regnite® Tablets for Restless Legs Syndrome in Japan
Astellas Pharma and XenoPort, Inc. (NASDAQ: XNPT) announced today that Regnite® (gabapentin enacarbil) has received marketing approval in Japan for the treatment of moderate-to-severe primary restless legs syndrome.
The New Drug Application (NDA) filing for Regnite employed a bridging strategy based on data supporting safety and efficacy from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan, as well as the RLS clinical program conducted by XenoPort in the United States and supporting pharmacokinetic studies conducted by XenoPort in Japanese subjects. Each of the efficacy studies showed that treatment with Regnite was associated with improvement in the International Restless Legs Syndrome rating scale score compared to placebo. Improvement over placebo was also observed on the investigator-rated clinical global impression of improvement scale.
The most commonly reported adverse events for Regnite were somnolence and dizziness, which were generally transient and mild to moderate in severity.
