Shire is expecting to resubmit its attention-deficit hyperactivity disorder drug SHP 465 (mixed amphetamine salts) in the US in the second quarter of 2017, after gathering extra paediatric data.
The drug, which was first filed in the US back in 2006, has the same active ingredient as the firm’s Adderall XR (mixed amphetamine salts), but is designed to provide symptom control for adults with ADHD for up to 16 hours as opposed to its predecessor’s 12.
While Shire intends to pursue an adult indication, US regulators have requested additional paediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population.
A short-term safety and efficacy study in patients aged six-17 years is scheduled to begin in August, with completion targeted for the last quarter of 2016. The drugmaker said it then expects to file a Class 2 resubmission for the drug in the second quarter of 2017, and is hoping to be able to launch later that year.