Shire announced positive topline results from the Phase 3 study, SHP465-305, evaluating SHP465 (triple-bead mixed amphetamine salts – MAS) in children and adolescents aged 6–17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).
SHP465-305 is a 4-week, randomized, double-blind, multicenter, placebo-controlled, dose-optimization, safety and efficacy study evaluating SHP465 administered as a daily morning dose for the treatment of ADHD. The primary endpoint was superiority to placebo on the change from baseline in ADHD-RS-IV (ADHD rating scale) total score.
Analysis of the study demonstrated that SHP465 significantly improved ADHD symptoms. It showed superiority to placebo on the change from baseline in ADHD-RS-IV total score, with a Least Squares (LS) mean difference from placebo at Week 4 of –9.9 (95% CI: –13 to –6.8, P<0.001). In addition, a significantly higher proportion of patients treated with SHP465 were rated improved on the clinical global impression improvement scale (CGI-I), a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication. SHP465 showed superiority to placebo on the CGI-I rating scale, with an LS mean difference from placebo at Week 4 of –0.8 (95% CI: –1.1 to –0.5, P<0.001).
Shire intends to include results from this study, along with data from other clinical studies, to support the Class 2 resubmission for FDA approval of SHP465 for the treatment of ADHD. SHP465 remains on track for a potential launch in the second half of 2017.
SHP465 (triple-bead mixed amphetamine salts) is an investigational oral stimulant.
For more information call (800) 536-7878 or visit Shire.com.