Date: 2016-04-28
Type of information: Results
phase: 3
Announcement: results
Company: Shire (UK - USA)
Product: SHP465 (triple-bead mixed amphetamine salts - MAS)
Action mechanism:
Disease: Attention-Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: CNS diseases - Mental diseases - Neurological diseases
Country: USA
Trial
details: This phase 3, randomized, double-blind, multi-center, placebo controlled, dose-optimization is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD. (NCT02466425)
Latest
news: * On April 4, 2016, Shire announced positive topline results from a four-week Phase 3, randomized, double-blind, multi-center, placebo-controlled, dose-optimization, safety and efficacy study, SHP465-305, in children and adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). SHP465 (triple-bead mixed amphetamine salts - MAS) is an investigational oral stimulant medication being evaluated in the U.S. as a potential treatment for ADHD. The primary efficacy analysis of study 305 demonstrated that SHP465, administered as a daily morning dose, was superior to placebo on the change from baseline in ADHD-RS-IV (ADHD rating scale) total score, with a Least Squares (LS) mean difference from placebo at Week 4 of -9.9 (95% CI: -13.0 to -6.8, p<0.001), suggesting a significant improvement in ADHD symptoms. SHP465 was also superior to placebo in the key secondary efficacy analysis on the clinical global impression improvement scale (CGI-I), with an LS mean difference from placebo at Week 4 of -0.8 (95% CI: -1.1 to -0.5, p<0.001), indicating a significantly higher proportion of patients were rated improved on the CGI-I rating scale. The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication. Treatment-emergent adverse events ? 5% for SHP 465-305 were decreased appetite, headache, insomnia, irritability, nausea, weight decrease and dizziness. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP465 studies and with other amphetamine compounds. The completion of SHP465-305 addresses an FDA requirement to evaluate the safety and efficacy of SHP465 in children and adolescents prior to filing a Class 2 resubmission of the medicine for FDA approval. Including study 305 and previous studies, Shire now has a database of 15 clinical studies evaluating SHP465 in more than 1,100 subjects. Once the pharmacokinetic study and an additional safety and efficacy Phase 3 trial in adults currently under way are complete later this year, Shire plans to add these study results to its existing SHP465 data set to submit a Class 2 resubmission for FDA approval of the medicine for treatment of ADHD. SHP465 remains on track for potential U.S. launch in the second half of 2017.
