Astellas Pharma and XenoPort have announced the introduction of Regnite (gabapentin enacarbil) extended-release tablets in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS).
Regnite, which was discovered by XenoPort, is dosed once-daily and delivers a new chemical entity that utilizes naturally-occurring, nutrient transporters in the gastrointestinal tract to achieve efficient absorption into the body.
After absorbtion, Regnite is rapidly converted into gabapentin, a compound thought to work by binding to certain calcium channels in nerve terminals.
The approved daily dose of Regnite, which provides dose-proportional and extended exposure of gabapentin, for the treatment of RLS is 600mg per day.
In 2005, Astellas obtained exclusive rights to develop and commercialize Regnite in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan.
Astellas' promotional efforts will focus on sleep and neurology specialists. Approximately 1,200 Astellas sales representatives are participating in the promotion of Regnite.
Restless legs syndrome is a neurological condition that is characterized by unpleasant and sometimes painful sensations in the legs that result in a compelling urge to move and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.