Shire announced top-line results from two Phase 4 efficacy and safety studies of Vyvanse (lisdexamfetamine dimesylate) compared to Concerta (methylphenidate HCl) in patients with Attention Deficit Hyperactivity Disorder (ADHD).
Study SPD489-406 and Study SPD489-405 were randomized, double-blind, multicenter, parallel-group, active-controlled efficacy and safety studies with a placebo reference arm. Both studies were designed to evaluate the efficacy of Vyvanse compared with Concerta in patients 13–17 years of age with ADHD based on DSM-IV-TR criteria (Study SPD489-406: N=547; Study SPD489-405: N=459). Patients were randomized to Vyvanse, Concerta, or placebo, respectively.
In Study SPD489-406, patients were treated for 6 weeks to evaluate safety and efficacy, followed by a 1-week safety follow-up period. The primary efficacy outcome was defined as the change from baseline at Week 6 (Visit 6) in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) total score. Results for Study SPD489-406 demonstrated that at the end of the study [Week 6 (Visit 6)], patients treated with Vyvanse experienced a mean 25.4 point reduction in ADHD-RS-IV total score vs. a 22.1 point reduction for Concerta, and a 17.0 point reduction for placebo. Vyvanse was found to be statistically superior to Concerta (P=0.0013) on the primary efficacy analysis, with an improvement of 3.4 points compared to Concerta on the ADHD-RS-IV total score.
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In Study SPD489-405, patients were treated for 8 weeks to evaluate safety and efficacy, followed by a 1-week safety follow-up period. The primary efficacy outcome was defined as the change from baseline at Week 8 (Visit 8) in the ADHD-RS-IV total score. At the end of Study SPD489-405 [Week 8 (Visit 8)], patients treated with Vyvanse experienced a mean 25.6 point reduction in ADHD-RS-IV total score compared with a 23.5 point reduction for Concerta, and a 13.4 point reduction for placebo. While not statistically significant (P=0.0717), Vyvanse was found to have a larger mean reduction (improvement) of 2.1 points compared to Concerta on the primary efficacy analysis.
Vyvanse is a CNS stimulant already approved for the treatment of ADHD in patients ≥6 years of age.
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