Andrew
07-28-05, 07:48 PM
Tue 26 Jul 2005 10:00 am CST
AUSTIN (myDNA News)
To learn more visit myDNA's ADHD Center Read More
An amended New Drug Application for a once-daily transdermal medication patch used to treat attention deficit hyperactivity disorder is under review by the FDA.
The patch is designed to be used by children ages 6 to 12. The revoultionary treatment approach, developed by Shire Pharmaceuticals Group and Noven Pharmaceuticals, Inc. allows continuous dispersal of medication through the skin into the bloodstream.
The FDA amendment included new clinical data demonstrating the efficacy, dosing, duration of wear and tolerability of the patch. The amendment provides information about a recent study involving 349 patients.
The study examined the use of the patch, formally known as MTS (methylphenidate transdermal system), over a seven week period in children between the ages of 6 and 12. Methylphenidate, the key ingredient in the patch, has been used for over 50 years to treat pediatric and adult ADHD. MTS will be available in 10 milligram (mg) (12.5 cm2), 16 mg (18.75 cm2), 20 mg (25 cm2) and 27 mg (37.5 cm2) strengths allowing for customized treatments.
Robert Findling, Professor of Psychiatry, Director, Division of Adolescent and Child Psychiatry, Case Western University, commented, "The children in clinical trials who received the methylphenidate transdermal system for the treatment of ADHD symptoms tolerated it will. If approved, this will be the first ADHD treatment available in a patch formulation, providing health care providers and parents with a useful tool to tailor individualized treatment for children with ADHD."
ADHD is a disease that affects nearly 3 to 5 percent of school-age children, approximately 2 million in the U.S, making it the most commonly diagnosed psychiatric disorder among children.
To learn more visit myDNA's ADHD Center Read More
Reviewed: July 27, 2005 Rick Nauert PhD
Source:
myDNA.com
http://www.mydna.com/health/mental/news/resources/news/200507/news_20050727_admt.html
AUSTIN (myDNA News)
To learn more visit myDNA's ADHD Center Read More
An amended New Drug Application for a once-daily transdermal medication patch used to treat attention deficit hyperactivity disorder is under review by the FDA.
The patch is designed to be used by children ages 6 to 12. The revoultionary treatment approach, developed by Shire Pharmaceuticals Group and Noven Pharmaceuticals, Inc. allows continuous dispersal of medication through the skin into the bloodstream.
The FDA amendment included new clinical data demonstrating the efficacy, dosing, duration of wear and tolerability of the patch. The amendment provides information about a recent study involving 349 patients.
The study examined the use of the patch, formally known as MTS (methylphenidate transdermal system), over a seven week period in children between the ages of 6 and 12. Methylphenidate, the key ingredient in the patch, has been used for over 50 years to treat pediatric and adult ADHD. MTS will be available in 10 milligram (mg) (12.5 cm2), 16 mg (18.75 cm2), 20 mg (25 cm2) and 27 mg (37.5 cm2) strengths allowing for customized treatments.
Robert Findling, Professor of Psychiatry, Director, Division of Adolescent and Child Psychiatry, Case Western University, commented, "The children in clinical trials who received the methylphenidate transdermal system for the treatment of ADHD symptoms tolerated it will. If approved, this will be the first ADHD treatment available in a patch formulation, providing health care providers and parents with a useful tool to tailor individualized treatment for children with ADHD."
ADHD is a disease that affects nearly 3 to 5 percent of school-age children, approximately 2 million in the U.S, making it the most commonly diagnosed psychiatric disorder among children.
To learn more visit myDNA's ADHD Center Read More
Reviewed: July 27, 2005 Rick Nauert PhD
Source:
myDNA.com
http://www.mydna.com/health/mental/news/resources/news/200507/news_20050727_admt.html