The three to four percent of American adults with attention deficit/ hyperactivity disorder (ADHD) can now find relief from their symptoms with a new medication clinically tested at the University of Iowa.
Strattera, approved by the U.S. Food and Drug Administration (FDA) in November 2002, is different from most ADHD drugs, as it is the first FDA-approved ADHD medication shown to be clinically effective for adults. It is also the first non-stimulant medication to be approved for treatment of ADHD. Eli Lilly and Company, which produces Strattera, began making the medication available in January.
ADHD is characterized by patterns of inattention, careless mistakes, difficulty waiting, forgetfulness, and restlessness. Patients can be classified in one of three subtypes: inattentive, hyperactive-impulsive, or a combination of the first two. The cause of ADHD is still unknown.
It is estimated that three to five percent of school-aged children and three to four percent of adults in the United States have ADHD. There is about a 65 percent chance of ADHD continuing from childhood into adulthood, according to Gary Gaffney, M.D., University of Iowa associate professor of psychiatry.
Strattera, or atomoxetine, is an oral capsule taken once or twice daily. Most treatments for ADHD, like Ritalin, are controlled substances and are strictly regulated by the FDA. This means that no refills on prescriptions are given, and there are complex rules for insurance and Medicaid reimbursement of these medications. Because Strattera is a non-controlled substance, patients can refill the prescription by phone and physicians can offer samples of the medication.
Strattera is a new option among older ADHD medications, like Ritalin and Adderall. The last new drug for ADHD was introduced in the 1970s, according to A.J. Allen, M.D., Ph.D., senior clinical research physician at Lilly.
"It was widely recognized that there was a need for a new kind of ADHD medication, one with a different mechanism of action from the stimulants," said Allen, also a UI Carver College of Medicine alumnus. "Not everyone with ADHD responds to stimulant medications. In addition, many children, adolescents and adults choose not to medicate because of concerns about existing stimulant medications."
While it is unclear exactly how Strattera works, scientists believe that Strattera blocks or slows the re-absorption of norepinephrine, a brain chemical considered important in regulating attention, impulse control and organization. This keeps more norepinephrine at work in the tiny spaces between neurons in the brain, Allen said.
Gaffney, along with Samuel Kuperman, M.D., UI professor of psychiatry, were investigators in clinical trials of Strattera held at the UI. Lilly included the results of the UI trials in the new drug application that was submitted to the FDA for approval of Strattera.
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