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FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults

Saturday, June 28, 2008 General News J E 4
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RARITAN, N.J., June 27 ADHD is the most common emotional,cognitive and behavioral disorder treated in children(1), and according to theNational Institute of Mental Health (NIMH), between 30 percent and 70 percentof children with ADHD continue to exhibit symptoms in the adult years(2). ADHDis thought to affect about eight million, or one in 20, adults in the UnitedStates(3), and research on the life span of the condition notes the disorderimpairs academic, social and occupational functioning(1), and is associatedwith academic underachievement, conduct problems, underemployment, motorvehicle safety and difficulties with personal relationships(1).

Today, there's a new treatment option for the millions of adults in theUnited States with ADHD: Johnson & Johnson Pharmaceutical Research &Development L.L.C. (J&JPRD) announced the U.S. Food and Drug Administration(FDA) approved J&JPRD's Supplemental New Drug Application (sNDA) forCONCERTA(R) treatment of ADHD in adults ages 18 to 65. The doses approved foradults range from 18 to 72 mg daily.

Today's approval expands the CONCERTA(R) indication from children andadolescents into adults with ADHD, and offers these patients a patented once-daily formulation. Using its unique OROS(R) delivery system, the CONCERTA(R)formulation delivers an initial dose of medication when the tablet isingested. Medication is then delivered into the bloodstream at a controlledrate throughout the day.

The CONCERTA(R) brand, which was the first 12-hour extended-releasemethylphenidate (MPH) treatment for ADHD, is the market leader for MPHtreatment of children and adolescents with ADHD. CONCERTA(R) is marketed inthe United States by McNeil Pediatrics(TM), Division of Ortho-McNeil-JanssenPharmaceuticals, Inc.

"What we've seen in the growing body of knowledge on adult ADHD suggests achallenging burden of impairment in everyday functioning," said Janet Vergis,President of McNeil Pediatrics(TM). "Recognizing this need -- and as themarket leader in extended-release MPH for children and adolescents -- we seetoday's approval as a treatment option milestone for adults with ADHD andtheir healthcare professionals. We are proud to offer patients ages 6 to 65with ADHD our CONCERTA(R) product knowledge based on more than seven years ofclinical experience."

Researchers examining ADHD across the lifespan have noted the condition isoften chronic, with prominent symptoms and impairment spanning into adulthood,and is often associated with co-occurring anxiety, mood and disruptivedisorders as well as substance abuse(3). According to the NIMH, ADHD isthought to be a biological condition, usually inherited, and tends to run insome families more than others. Often when a child is diagnosed with thedisorder, a parent will recognize that he or she had many of the samesymptoms, and for the first time, will begin to understand some of the traitsthat have troubled them for years(4). All aspects of an individual's life mustbe considered in the diagnosis and treatment of ADHD(3).

Today's FDA approval was based on clinical trial data in adults ages 18 to65. In these studies, use of CONCERTA(R) was shown to significantly improveADHD symptoms such as attention, impulsivity and hyperactivity compared toplacebo, and the medication was shown to be generally well tolerated.

About CONCERTA(R)

CONCERTA(R) is approved for the treatment of attention deficithyperactivity disorder (ADHD) as part of a total treatment program that mayinclude counseling or other therapies.

IMPORTANT SAFETY INFORMATION

Talk to your healthcare professional for a proper diagnosis and treatmentof ADHD. Only a healthcare professional can decide whether medication is rightfor you or your child.

CONCERTA(R) should not be taken by patients who have: allergies tomethylphenidate or other ingredients in CONCERTA(R); significant anxi
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