Shire establishes regulatory path with FDA for SHP465 in ADHD

Ireland-headquartered drugmaker Shire (LSE: SHP) has reached an agreement with the US Food and Drug Administration on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts) for attention-deficit hyperactivity disorder (ADHD).

SHP465 is an investigational oral stimulant medication being evaluated as a potential treatment for ADHD in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in patients aged six-17. Shire intends to pursue an adult indication but the FDA is requesting additional pediatric data to better understand potential side effects of the therapy on children, in the event of use in this population.

Shire expects that the trial will begin in August 2015, and will be completed by the last quarter of 2016, and anticipates to submit to the FDA by the second quarter of 2017. This would be a Class 2 resubmission for approval of PSH465 as a treatment of ADHD in adults, typically entailing a six-month review. Should FDA grant approval, Shire anticipates launching the medicine in the second half of 2017.