Shire agrees regulatory pathway with FDA for SHP 465 (triple-bead mixed amphetamine salts) for ADHD in Adults.

Shire plc announces that it has reached an agreement with the FDA on a clear regulatory path for SHP 465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD (ages 6-17). While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP 465 on children with ADHD in the event of use in this population. The Company anticipates the clinical trial�s first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP 465 as a treatment for ADHD in adults, which typically entails a 6-month review. 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.