Positive late-stage trial for Shire ADHD patch

The methylphenidate transdermal system (MTS) patch was developed by Noven Pharmaceuticals and is licensed to Shire. It combines the active ingredient of methylphenidate with Noven’s patented DOT Matrix transdermal technology.

This transdermal delivery system is designed to provide continuous medication release throughout the day. The patch releases medication that passes through the skin and directly into the bloodstream.

Data from phase II and phase III clinical trials presented at the US Psychiatric and Mental Health Congress in Las Vegas, demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.

In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children’s overall symptoms of ADHD, compared to a placebo, as measured by scores on the ADHD Rating Scale. By the study’s end, mean ADHD-RS scores declined -24.2 points (56%) from baseline for children treated with MTS versus a decline of -9.9 (24%) for those treated with placebo.

“While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD,” said Dr Frank Lopez, developmental pediatrician at the Children’s Developmental Center, Florida.