Shire announced positive topline results from a four-week randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration, efficacy and safety study, SHP465-306, in 275 adults aged 18-55 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, a therapeutic area with significant need for additional treatment options.
The primary efficacy analysis of study 306 showed that SHP465 12.5mg and 37.5mg, both administered as a daily morning dose, were superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (ADHD-RS) total score, with Least Squares mean differences from placebo at Week 4 of -8.1 (95percent CI: -11.7 to -4.4, p<0.001) for 12.5mg, and -13.3 (95percent CI: -17.0 to -9.6, p<0.001) for 37.5mg. SHP465 12.5mg and 37.5mg doses were also significantly better than placebo on the key secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), at Week 4 of -0.8 (95percent CI: -1.1 to -0.4, p<0.001) for 12.5mg, and -1.2 (95percent CI: -1.6 to -0.9, p<0.001), suggesting a marked clinical improvement in patients’ global functioning. 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 ≥ 5percent for either dose of SHP465 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP465 studies and with other amphetamine compounds.
Matthew Brams, M.D., Clinical Assistant Professor at Baylor College of Medicine and principal investigator for study 306, added: “ADHD affects adults in multiple ways and, therefore, physicians need additional treatment options. Based upon this study’s findings, and pending the U.S. FDA’s review, SHP465 may provide a promising treatment option for physicians and patients alike.”
“Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder,” said Philip J. Vickers, Ph.D., Head of Research and Development at Shire. “We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.”
Shire plans to file a Class 2 Resubmission of the New Drug Application (NDA) with the U.S. Food and Drug Administration by the end of 2016; the program is on track for potential U.S. approval in the second half of 2017.
Filed Under: Drug Discovery