Posted by djmmm on April 10, 2002, at 7:40:28
Noven Transdermal ADHD Treatment Looks Good in Phase III
MIAMI (Reuters) Apr 02 - Noven Pharmaceuticals Inc. on Monday said an initial review of pivotal-stage trial results show its experimental skin patch for treatment of attention deficit hyperactivity disorder is effective.
Miami-based Noven said it expects to use data from the phase III trial of the MethyPatch transdermal patch to file a new drug application with the U.S. Food and Drug Administration this summer. The patch delivers the drug methylphenidate transdermally throughout the day.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, MethyPatch offered highly statistically significant improvement in patient attention and behavior compared to placebo, Noven said.
If approved by the FDA, MethyPatch is expected to reach the US market in the second half of 2003 as the first transdermal therapy available for ADHD, the company said. All presently-approved ADHD medications are delivered orally.
ADHD, characterized by developmentally inappropriate impulsivity, inattention and hyperactivity, affects 3% to 5% of school-age children, and an estimated 1.5 million children are currently on ADHD medication, Noven said.
In early-afternoon trade on Tuesday, shares of Noven were up $1.45, or 7.25%, at $21.45 on the NASDAQ.
poster:djmmm
thread:102607
URL: http://www.dr-bob.org/babble/20020408/msgs/102607.html