Posted by psychosage on September 7, 2004, at 21:15:31
If you haven't heard...
http://uk.biz.yahoo.com/040820/241/f0tyq.html
Cephalon ADHD drug on course for FDA filing
A new once-daily dosage of Cephalon (NASDAQ: CEPH - news) 's modafinil drug can significantly improve symptoms of attention deficit hyperactivity disorder in children and adolescents, a clinical study has found.A new once-daily dosage of Cephalon's modafinil drug can significantly improve symptoms of attention deficit hyperactivity disorder in children and adolescents, a clinical study has found.
Based upon the results of the phase III trial, the biotech company plans to bring forward the filing of its FDA application for the drug from the first quarter of 2005 to the fourth quarter of 2004.
In three nine-week, double-blind, placebo-controlled studies, 600 children and adolescents between the ages of six and 17 with attention deficit hyperactivity disorder (ADHD) were administered with either placebo or 340mg and 425mg doses of modafinil. All of the modafinil treated groups showed strong and consistent symptom improvement compared to placebo. The data from the completed study will be presented over the next 12 months.
Modafinil is currently available as Provigil in 100 and 200 milligrams and is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work sleep disorder. 2003 sales of the drug exceeded $291 million. Modafinil for the treatment of children and adolescents with ADHD will be manufactured as smaller, film-coated tablets in unique dosage strengths.
ADHD is one of the most common psychiatric disorders among children, affecting three to five percent of American children. The most common ADHD behaviors fall into three categories: inattention, hyperactivity, and impulsivity. The large and growing market for treatments for ADHD currently exceeds several billion dollars.
poster:psychosage
thread:387853
URL: http://www.dr-bob.org/babble/20040904/msgs/387853.html