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news.Astellas Pharma and XenoPort announced that Regnite (gabapentin enacarbil), used to treat moderate-to-severe primary restless legs syndrome (RLS), has received marketing approval in Japan.
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The New Drug Application (NDA) filing for Regnite was backed by the safety and efficacy data from the Phase 2 study in RLS patients.
The long-term safety study conducted by Astellas in Japan, as well as the RLS clinical program conducted by XenoPort in the US and supporting pharmacokinetic studies conducted by XenoPort in Japanese subjects, was also taken into consideration.
The studies demonstrated that treatment with Regnite was associated with improvement in the International Restless Legs Syndrome rating scale score compared to placebo.
The approval of Regnite in Japan entitles XenoPort to an additional milestone payment of $10m under its collaboration agreement with Astellas.