These trial results are expected to be included as part of an amendment to the new drug application for the methylphenidate transdermal system (MTS) product currently pending at the FDA. Both Noven and Shire believe that the studies will address the issues raised by the FDA’s review in April 2003.
The two studies, a phase II study involving 79 patients over a seven-week period and a phase III study involving 268 patients over a seven-week period, examined MTS in children between the ages of six and 12 previously diagnosed with ADHD. In these studies, use of MTS was well tolerated and the objectives of both studies were achieved.
“These results demonstrate that MTS has the potential to provide significant benefits for children with ADHD, especially those that have difficulty taking oral medications and those that find a once-a-day patch more appropriate for their lifestyle,” said Matthew Emmens, CEO of Shire. “As the ADHD market develops, new choices of treatment are emerging, including specialized delivery systems (such as MTS) to meet the needs of different patients.”
If approved, the patch could be a strong addition to Shire’s ADHD portfolio, taking its place alongside Adderall XR, the most prescribed ADHD treatment in the US.
Shire is expected to release additional details of the trial results following further analysis and as part of an R&D update in May 2005.