Shire plc has reached an agreement with the FDA on a regulatory path for SHP465 (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 says it will pursue an adult indication, 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.
The company said in a press release that it 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 SHP465 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.
“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 J. Vickers, Ph.D., Head of Research and Development, Shire. “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.”
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