Trial results of SHP 465 (mixed salts of a single entity amphetamine) show benefits in Attention-Deficit/Hyperactivity Disorder- Shire

Shire has 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, of SHP 465 (mixed salts of a single entity amphetamine) in 275 adults aged 18-55 years with Attention-Deficit/Hyperactivity Disorder (ADHD). SHP 465 (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 for 12.5mg, and -13.3 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 for 12.5mg, and -1.2, 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 at least 5% 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.

Comment: Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire�s announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.