SHP465 triple-bead MAS regulatory update

Shire said it now expects to resubmit an NDA in 2Q17 for SHP465 to treat ADHD in adults. The company agreed to conduct a pediatric efficacy and safety study of the triple-bead mixed amphetamine salts (MAS) before resubmission. It expects to begin the trial in August and complete it in 4Q16.

Last October, FDA requested additional pediatric data to support the resubmission. Shire said FDA wanted to better understand the potential effects of SHP465 on children with ADHD “in the event of use in this population” (see BioCentury, Oct. 13, 2014). ...