Updated on 10 July 2012
Singapore: Astellas Pharma and XenoPort have launched Regnite (gabapentin enacarbil) extended-release tablets. Regnite is approved in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Astellas' promotional efforts will focus on sleep and neurology specialists. Approximately 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.
Regnite was approved on January 18, 2012, by the Japanese Ministry of Health, Labour and Welfare for the treatment of RLS in Japan.
In 2005, Astellas obtained exclusive rights to develop and commercialize Regnite in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. XenoPort has received payments of $65 million to date under the collaboration agreement. XenoPort is eligible to receive potential additional clinical and regulatory milestone payments totaling up to $20 million. Under the agreement, XenoPort is also eligible to receive royalties on net sales of Regnite in the Astellas territory at a royalty rate in the high-teens on a percentage basis.