A review of trial data shows
that an experimental skin patch for treating attention-deficit hyperactivity
disorder (ADHD) is effective, the patch's maker Noven Pharmaceuticals
Inc. April 1.
Miami-based Noven said it expects
to use data from the phase 3 clinical trial of the MethyPatch transdermal
patch to file a new drug application with the US Food and Drug Administration
this summer. The patch delivers the drug Ritalin, or methylphenidate,
throughout the day, through the skin.
The trial, involving over 200
patients between the ages of 6 and 12, measured teacher ratings of patient
attention and behavior using a standard rating scale. By this measure,
Noven said MethyPatch offered highly statistically significant improvement
in patient attention and behavior compared to placebo.
If approved by the FDA, Noven
said it expects MethyPatch will reach the US market in the second
half of 2003, and that it will be the first transdermal therapy
available for ADHD. All presently approved ADHD medications are delivered
orally.
Noven
April 1, 2002