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

Concerta now available for patients with ADHD ages 6 to 65

RARITAN, N.J., June 27, 2008 /PRNewswire/ -- ADHD is the most common emotional, cognitive and behavioral disorder treated in children(1), and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 percent of children with ADHD continue to exhibit symptoms in the adult years(2). ADHD is thought to affect about eight million, or one in 20, adults in the United States(3), and research on the life span of the condition notes the disorder impairs academic, social and occupational functioning(1), and is associated with academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships(1).

Today, there's a new treatment option for the millions of adults in the United 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) for Concerta treatment of ADHD in adults ages 18 to 65. The doses approved for adults range from 18 to 72 mg daily.

Today's approval expands the Concerta indication from children and adolescents into adults with ADHD, and offers these patients a patented once- daily formulation. Using its unique OROS delivery system, the Concerta formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day.

The Concerta brand, which was the first 12-hour extended-release methylphenidate (MPH) treatment for ADHD, is the market leader for MPH treatment of children and adolescents with ADHD. Concerta is marketed in the United States by McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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

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

Today's FDA approval was based on clinical trial data in adults ages 18 to 65. In these studies, use of Concerta was shown to significantly improve ADHD symptoms such as attention, impulsivity and hyperactivity compared to placebo, and the medication was shown to be generally well tolerated.

About Concerta

Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.

Important Safety Information

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

Concerta should not be taken by patients who have: allergies to methylphenidate or other ingredients in Concerta; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under six years of age should not take Concerta.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking Concerta.

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that Concerta does not adversely affect your ability to engage in such activities.

The most common adverse reaction (> 5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Visit http://www.concerta.net/concerta/pages/full.jsp for complete prescribing information.

About McNeil Pediatrics

McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics markets Concerta for the treatment of children, adolescents and adults with ADHD in the United States. McNeil Pediatrics continues to explore other new therapies to meet the needs of children and the pediatric community. Visit http://www.mcneilpediatrics.net for more information.

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&JPRD) is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

References

(1) Wilens, T.E., Dodson, W. A Clinical Perspective of Attention-Deficit Hyperactivity Disorder into Adulthood. Journal of Clinical Psychology 65:10. October 2004.

(2) National Institute of Mental Health. "ADHD in Adults." Available at http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity- disorder-adhd/index.shtml. Accessed June 19, 2008.

(3) Wilens, T.E., Biederman J., Spencer T.J. Attention Deficit/Hyperactivity Disorder Across the Lifespan. Annual Review of Medicine, Vol. 53. 2002.

(4) National Institute of Mental Health. "Genetics." Available at http://www.nimh.nih.gov/health/publications/adhd/attention-deficit- hyperactivity-disorder-in-adults.shtml. Accessed June 19, 2008.

     Media                                 Investors

     Tricia Geoghegan:  (609) 730-3746     Louise Mehrotra: (732) 524-6491

     tgeogheg@janus.jnj.com                Johnson & Johnson


                                           Lesley Fishman: (732) 524-3922

                                           Johnson & Johnson

CONTACT: Media, Tricia Geoghegan of Johnson & Johnson PharmaceuticalResearch & Development L.L.C., +1-609-730-3746, ; orInvestors, Louise Mehrotra, +1-732-524-6491, or Lesley Fishman,+1-732-524-3922, both of Johnson & Johnson tgeogheg@janus.jnj.com

Web site: http://www.mcneilpediatrics.net/

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Posted: June 2008


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