Cephalon Inc announced results from three multi-centre clinical trials, which show that new proprietary once-daily dosage forms of modafinil significantly improve symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.
In three nine-week, double-blind, placebo-controlled studies, 600 children and adolescents between the ages of six and 17 with ADHD were randomized to either placebo or an optimized new proprietary dosage form of modafinil. The primary endpoint in all studies was the teacher-completed school version of the ADHD Rating Scale IV. All of the modafinil treated groups showed a highly statistically significant improvement on the primary endpoint compared to placebo (p<0.0001). Modafinil was generally well tolerated, and the most common side effects observed in these studies were consistent with those observed in other studies of this compound and included insomnia, headache and loss of appetite. The complete Phase III study data are expected to be presented at major medical meetings over the next 12 months, a company release said.
"Because children metabolize modafinil differently from adults, our clinical efforts focused on identification of optimal doses of modafinil for these studies," said Dr. Paul Blake, senior vice president of Clinical Research and Regulatory Affairs at Cephalon. "The result was the development of proprietary dosage strengths of 340 and 425 milligrams, which in these Phase III studies demonstrated robust symptom improvement in children and adolescents with ADHD. The most encouraging aspects of these results were the strength and consistency of the effects of modafinil across the three studies and the robust effects of modafinil on both the inattentive and hyperactive symptoms of ADHD," he added.
Based upon the demonstrated strength of the study results, the company plans to accelerate the filing of its application with the Food and Drug Administration from the first quarter of 2005 to the fourth quarter of 2004.
Frank Baldino Jr, chairman and CEO of Cephalon, said, "We are excited about these data and the promise they hold for the ADHD community. We expect this product, once approved, to command a substantial presence in this large and growing market that today exceeds several billion dollars. With its excellent clinical profile and strong intellectual property protection for use in ADHD, we anticipate this product will be an important contributor to Cephalon's revenue growth for many years to come."
Modafinil (Provigil C-IV Tablets) is currently available 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.
According to the National Institutes of Mental Health, ADHD is one of the most common psychiatric disorders among children, affecting three to five percent of American children. ADHD is associated with dysfunction in the prefrontal cortex area of the brain. The most common ADHD behaviours fall into three categories: inattention, hyperactivity, and impulsivity. A diagnosis of ADHD is generally made when these behaviours become excessive, long-term, and pervasive.