Pediatric Data Needed for Adult ADHD Drug Approval

Even though Shire is seeking an adult indication for its investigational ADHD treatment, the FDA is requesting pediatric data before deliberating the drug’s approval.

The FDA asked for additional pediatric data to better understand the potential side effects of the triple-bead mixed amphetamine salts (SHP465) on children aged 6 to 17 years with ADHD, in the event of its use in this population.

To provide these additional data, Shire has agreed to conduct a short-term efficacy and safety study, which it plans to complete by the fourth quarter of 2016.

Following this trial’s conclusion, Shire intends to submit a Class 2 resubmission for SHP465’s approval by the second quarter of 2017. Pending FDA approval, which typically follows a 6-month review, Shire anticipates launching the drug in the second half of 2017 with 3 years of Hatch-Waxman exclusivity.

“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 Philip Vickers, head of research and development at Shire, in a press release. “We’re pleased that we now have a clear regulatory path to bring this investigational medicine forward as a potential treatment option for adults with ADHD.”