In the single dose, single-site, randomised, placebo- and active-controlled study, 135 subjects received Vyvanse 20mg, 50mg, 70mg, placebo or the active comparator (armodafinil 250mg (NUVIGIL)).
On the primary endpoint, all the groups improved objective wakefulness as compared to placebo.
Additional pre-specified analyses revealed that Vyvanse 70mg demonstrated improvement in objective wakefulness compared to armodafinil.
However, no significant difference was demonstrated between Vyvanse 50mg and armodafinil, and Vyvanse 20mg was demonstrated as inferior to armodafinil.
No conclusions of comparability between Vyvanse and armodafinil can be obtained from this signal finding study.
Based on these findings Shire is planning to review potential development pathways with health authorities for Vyvanse as a possible EDS treatment option
Vyvanse is a prescription medicine currently approved in the US, Canada and Brazil for the treatment of Attention deficit hyperactivity disorder (ADHD).