Astellas launches RLS drug Regnite in Japan

Japanese drug major Astellas Pharma (TOY: 4503) says that Regnite (gabapentin enacarbil) extended-release tablets, a treatment for restless legs syndrome (RLS), will be launched in Japan today (July 10).

Regnite, which was licensed by Astellas from USA-based XenoPort (Nasdaq: XNPT) was approved early this year by the Japanese Ministry of Health, Labor and Welfare for the treatment of moderate-to-severe primary RLS (The Pharma Letter January 18). Astellas’ promotional efforts will focus on sleep and neurology specialists. Around 1,200 Astellas sales representatives will participate in the promotion of Regnite.

Discovered by XenoPort, Regnite is dosed once-daily and delivers a new chemical entity that utilizes naturally-occurring, high-capacity, nutrient transporters in the gastrointestinal tract to achieve efficient absorption into the body. Once absorbed, Regnite is rapidly converted into gabapentin, a compound thought to work by binding to certain calcium channels in nerve terminals. Regnite provides dose-proportional and extended exposure of gabapentin. The approved daily dose of Regnite for the treatment of RLS is 600 mg per day. The National Health Insurance (NHI) drug price per 300mg tablet of Regnite is 98.50 yen ($1.24).