Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical, announced a Phase II trial of its d-Amphetamine Transdermal System (d-ATS), a skin patch designed to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents.
The trial will recruit about 90 children and young people between 6 and 17 years old at 5 sites, and should complete mid-2013. According to Noven and its parent company Hisamitsu, there is currently no approved amphetamine-based transdermal treatment options available for ADHD. Noven's Daytrana methylphenidate transdermal system is available in the U.S.
ADHD, which affects an estimated 3% to 5% of children in the U.S., is often treated with stimulants, including amphetamines, but these can be open to abuse. Transdermal formulations are likely to be harder to abuse, and deliver a controlled dose over a longer period.
Noven came under fire from the FDA in 2011, for poor process validation and for running equipment unable to perform its intended function.
- read the press release