FDA Approves New ADHD Medication; Intuniv

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Main Category: ADHD
Article Date: 28 Feb 2011 - 14:00 PDT


ADHD is one of the most common childhood psychiatric disorders. In the United States, the prevalence of ADHD is approximately three to seven percent in school-aged children according to the Centers for Disease Control and Prevention (CDC). This week the FDA has approved a new drug to treat this condition called INTUNIV manufactured by Shire.

In the United States, 37% of those with ADHD do not get a high school diploma even though many of them will receive special education services.

Robert Findling, MD, Director of Child & Adolescent Psychiatry at University Hospitals Case Medical Center and Professor of Psychiatry & Pediatrics at Case Western Reserve University School of Medicine states:

"This approval of INTUNIV for treating ADHD as adjunctive therapy to a stimulant offers physicians a new treatment option for children and adolescents with ADHD who are having a suboptimal response to their current stimulant therapy. In this study, the once-daily dosing of INTUNIV was effective when taken in the morning or the evening, giving physicians flexibility when it comes to treating their patients with ADHD."

The approval is based on results from a 9-week placebo-controlled study of INTUNIV when given in combination with a stimulant, in children and adolescents with ADHD.

Attention deficit hyperactivity disorder is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.

ADHD is diagnosed two to four times more frequently in boys than in girls, though studies suggest this discrepancy may be partially due to subjective bias of referring teachers. ADHD management usually involves some combination of medications, behavior modifications, lifestyle changes, and counseling. Its symptoms can be difficult to differentiate from other disorders, increasing the likelihood that the diagnosis of ADHD will be missed.] Additionally, most clinicians have not received formal training in the assessment and treatment of ADHD, particularly in adult patients.

The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder.

Michael Yasick, Senior Vice President of Shire's ADHD Business Unit continues:

"This approval marks a significant development in our ADHD portfolio - one that may help to address symptoms that many children with ADHD may experience while on stimulant treatment. We understand that every child is unique, and it is our goal to offer treatment options for ADHD in a variety of situations, whether a child could benefit from treatment with a stimulant, nonstimulant, or both."

Many of the symptoms of ADHD occur from time to time in everyone; in patients with ADHD, the frequency of these symptoms is greater and patients' lives are significantly impaired. Impairment must occur in multiple settings to be classified as ADHD. As with many other psychiatric and medical disorders, the formal diagnosis is made by a qualified professional in the field based on a set number of criteria. In the USA these criteria are laid down by the American Psychiatric Association in their Diagnostic and Statistical Manual of Mental Disorders.

ADHD's global prevalence is estimated at 5% in people under the age of 19. There is, however, both geographical and local variability among studies. Geographically, children in North America appear to have a higher rate of ADHD than children in Africa and the Middle East, well published studies have found rates of ADHD as low as 2% and as high as 14% among school aged children. The rates of diagnosis and treatment of ADHD are also much higher on the East Coast of the USA than on the West Coast.

Rates of ADHD diagnosis and treatment have increased in both the UK and the USA since the 1970s. In the UK an estimated 0.5 per 1,000 children had ADHD in the 1970s, while 3 per 1,000 received ADHD medications in the late 1990s. In the USA in the 1970s 12 per 1,000 children had the diagnosis, while in the late 1990s, 34 per 1,000 had the diagnosis and the numbers continue to increase.

Source: Shire News Release

Written by Sy Kraft, B.A.


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