Children, Adults Taking New ADHD Drug Enjoying Better Lifestyle
October 09, 2000
A new drug used to treat attention deficit hyperactivity disorder - one that was studied during clinical trials at the University of Rochester Medical Center and recently approved by the U.S. Food and Drug Administration - is already being dispensed locally at Strong Memorial Hospital and Children's Hospital at Strong.
Concerta is the first drug that effectively treats attention deficit hyperactivity disorder (ADHD) with a single dose of medicine each day. It is methylphenidate - the most prescribed remedy for ADHD - given to children and adults through a different delivery system, one that provides sustained relief of symptoms throughout the day.
ADHD is a medical condition characterized by symptoms of inattention and/or hyperactivity displayed by millions of children and adults. According to the National Institutes of Health, it is one of the most common mental disorders among children, affecting between 3 and 5 percent of U.S. school-aged children.
Before Concerta, there were no once-daily methylphenidate medications for ADHD that worked effectively throughout the entire day. Other medications sometimes require two or three doses per day to achieve the desired improvement in symptoms, making management difficult and increasing the potential for side effects.
"One of the most important benefits of this new drug is that children only have to take one a day, in the morning," says Donna Palumbo, assistant professor of neurology and pediatrics at the University of Rochester Medical Center. "Now, they won't have to take it two or three times a day, and students can enjoy a more regular school day."
In addition to being better able to concentrate - and better behaved - in class, children will benefit from feeling more a part of the regular crowd.
"Many children feel stigmatized when they have to obtain medicine from the school nurse, and they don't want their friends to know about it," says Palumbo, who also serves as director of the Strong Neurology ADHD Clinic. "When that happens, children sometimes decide not to take their medication, and symptoms become problematic."
Concerta was evaluated in three studies of 416 children ages 6-12. The Neurology Department at Strong Memorial Hospital was one of 13 sites nationwide chosen to participate in the trials, which started approximately two years ago.
The drug, manufactured by ALZA Corp., employs an advanced form of the company's patented OROS technology, which uses osmotic pressure to deliver medication at a controlled rate. When first swallowed, the outside layer of the pill provides immediate relief for ADHD symptoms.
Once in the body's gastrointestinal tract, water enters the osmotic system and dissolves or suspends the drug in the tablet's core. The drug is then released through a laser-drilled hole in the membrane at a controlled rate. This can be a significant benefit for patients by providing controlled symptom relief and reducing the number of daily doses compared to conventional therapies, with fewer side effects.
The OROS system has been used safely for nearly 20 years in widely accepted prescription and over-the-counter medications, including medications taken by children.
"The big breakthrough with Concerta is that the outer layer of medication provides immediate relief, while the inner layers provide medication to sustain the drug's benefit throughout the day," Palumbo says. "It is delivered in an ascending dosage, ensuring true 10 to 20-hour efficacy, and no peaks and valleys, so the medication doesn't wear off abruptly."
The University of Rochester Medical Center was chosen to participate in the study because The Clinical Trials Coordination Center in the Department of Neurology has an international reputation of excellence in developing, implementing and administering clinical trials. Palumbo is also overseeing two additional ADHD clinical trials, and will begin two more this fall, one of which is NIH-funded.
"This is an exciting time for those of us who treat ADHD," Palumbo says. "Within the next couple of years, we will likely have many more treatment options available."