Shire clears development path for SHP465
This article was originally published in Scrip
Shire has agreed an updated development pathway with the US FDA for its investigational attention-deficit/hyperactivity disorder (ADHD) drug, SHP465 (triple-bead mixed amphetamine salts) – a product which has hovered in regulatory limbo for years.
Shire intends to pursue the product as a treatment for adults; however it will this year conduct a short-term efficacy and safety study in pediatric patients with ADHD (ages 6-17). The company said the FDA is requesting this additional pediatric data, "to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population."
Shire 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. It then expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults.
"Adult patients with ADHD represent the fastest growing segment of the overall ADHD patient population," Shire said.
Shire initially submitted an NDA for SHP465 in 2006. In April 2014, the FDA clarified that Shire could resubmit SHP465 as a class 2 resubmission, but the agency requested the inclusion of pediatric data for the drug.
"We believe SHP465 has the potential to be an important treatment option for adults with ADHD, which is why we worked so diligently with the FDA to determine what additional clinical data would be necessary for Shire to finalize our resubmission plans for this medicine," said Dr Philip J Vickers, head of R&D at Shire.