According to BioSpace, the MHRA has accepted for review a marketing authorisation application for lisdexamfetamine dimesylate (Venvanse®), intended for use in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).  The MHRA will act as the Reference Member State for this Decentralised Procedure, which will initially include eight European countries.

Lisdexamfetamine is a long-acting (once-daily) prodrug of dextroamfetamine that is already approved in the US and Canada (brand name Vyvanase®). The current application follows the completion of a European Phase III study of Venvanse® in 336 children and adolescents (aged 6 to 17 years) with ADHD [no details of the study are included in the report].