29th Jun 2016 11:37
SAINT HELIER (Alliance News) - Shire PLC 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.
The company said 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 in ADHD symptom improvement.
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.
Shire plans to file a Class 2 Resubmission of the NDA with the US FDA by the end of 2016. The company said the programme is on track for potential US approval in the second half of 2017.
Copyright RTT News/dpa-AFX
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