Good news/not-so-good news for two Vyvanse Phase 4 trials


In a forced-dose titration study, named SPD489-406, Shire's (SHPG +1.3%) Vyvanse (lisdexamfetamine dimesylate) was statistically superior to Concerta (methylphenidate) in the primary efficacy analysis. In the dose optimization study, SPD489-405, neither product demonstrated superiority.

The two Phase 4 trials compared the two products with a placebo reference arm in adolescents ages 13 - 17 diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Shire plans to present the data at a future scientific meeting.

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