Vyvanse positive in European Phase III study for ADHD

Vyvanse- lisdexamfetamine (LDX) from Shire is the long acting, prodrug of dexamfetamine for the treatment of ADHD and is currently licensed only in the US, Canada and Brazil. A study, conducted at 48 sites across Europe, showed that LDX demonstrated efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects of amfetamine treatment and previous LDX trials. The study will support the clinical package for European MAA filing. Three hundred and thirty six patients were randomised to receive LDX, osmotic-controlled extended-release methylphenidate (OROS-MPH), that is Concerta/Concerta LA, or placebo, over a period of seven weeks. The primary measure was the change in total score of the ADHD-RS-IV of LDX vs. placebo. At baseline, the ADHD-RS-IV total score was 40.7, 41.0, and 40.5 for subjects receiving LDX, placebo, and OROS-MPH respectively. At endpoint, the ADHD-RS-IV total score was 16.0 for LDX, 34.8 for placebo, and 21.7 for OROS-MPH. Results showed improvement of symptoms from 78% of patients in the LDX group, 14% in the placebo group, and 61% in the OROS-MPH group.