Navigation Links
New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo

Interim Results From Open-Label Follow-up Include Longer-term Safety


BOSTON, Oct. 26 /PRNewswire/ -- Adults with Attention Deficit Hyperactivity Disorder (ADHD) treated with CONCERTA(R) OROS(R) methylphenidate HCl Extended-release Tablets showed significant improvements in ADHD symptom management compared to adults taking placebo, according to study results presented today at a major psychiatric medical meeting.

"Pharmacological treatment of children and adolescents with ADHD is clearly established but relatively less is known about the treatment of adults with ADHD," notes the study's medical director, Sally Berry, M.D., PhD., of Johnson & Johnson Pharmaceutical Research and Development, LLC. "We're encouraged that the CONCERTA(R) findings presented today -- in which CONCERTA(R) significantly improved ADHD symptom management in adults -- can benefit the growing body of knowledge in this important therapeutic area." The data presented today are part of a Supplemental New Drug Application (sNDA) submitted in August 2007 to the Food and Drug Administration for use of CONCERTA(R) to treat adults with ADHD. CONCERTA(R) is already approved for the treatment of ADHD in children and adolescents ages six to 17.

About the Study

In the study presented today, efficacy was measured as a change in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. The results showed that CONCERTA(R) achieved a significantly superior reduction in AISRS total score compared to placebo (p=0.012) (mean change was -10.6 +/-1.09 for the CONCERTA(R) group vs. -6.8 +/-1.06 for the placebo group.

In addition, CONCERTA(R) was significantly superior compared to placebo for the key secondary efficacy variables: change in Clinical Global Impression-Improvement (CGI-I) rating (p=0.008); change in Conners' Adult ADHD Rating Scale-Self Report (CAARS-S:S) total score (p=0.029) and change in percent of subjects meeting pre-defined Responder criteria (p=0.009).

In the study, 229 patients with ADHD aged 18-65 years were randomized to receive CONCERTA(R) 36-108 mg/day or placebo, for seven weeks. The final analysis set contained data from 226 patients(a). Patients in the CONCERTA(R) group received a starting dose of 36 mg/day and the dose was increased in 18 mg increments every seven days (+/-2 days) for up to five weeks until response (AISRS scores decreased by 30% and CGI-I rating of 1 "very much" or 2 "much" improved) was achieved or titration to the maximum dose of 108 mg. The dose could be reduced one time during the study for tolerability reasons. The mean final dose was 67.7 mg/day.

Adverse events were reported by 93 (84.5%) of patients in the CONCERTA(R) group compared with 74 (63.8%) in the placebo group. The most commonly reported adverse events with CONCERTA(R) included decreased appetite (25.5%), headache (25.5%), dry mouth (20%), anxiety (16.4%), nausea (12.7%), increased blood pressure (10%), insomnia (9.1%), initial insomnia (7.3%), increased heart rate (7.3%), bruxism (6.4%), irritability (6.4%) and muscle tightness (6.4%). There were no serious treatment emergent adverse events reported and 16 (14.5%) and 6 (5.2%) subjects in the CONCERTA(R) and placebo groups, respectively, discontinued due to adverse events.

Today's data presentation included interim results from a long-term, open-label safety study. A similar dose titration protocol was used as in the double-blind study during the first weeks of the study after which the dose was flexible within the range of 36 to 108 mg. Interim results show that CONCERTA(R) was well tolerated in an adult population with ADHD in a dose range from 36mg to 108 mg per day for up to six months.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable neuropsychiatric condition, which includes inattention, hyperactivity and impulsivity. According to the National Institutes of Health (NIH), ADHD is one of the most common mental disorders in childhood. It affects an estimated four million children and adolescents in the United States. Although once considered to be a disorder only seen in children, ADHD is now known to be a common neuropsychiatric disorder associated with a wide range of functional impairments throughout the lifespan, according to the Journal American Occupational Environmental Medicine (Kessler, RC et al 2005.)


CONCERTA(R) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages six-17. For more information about CONCERTA(R), including full U.S. prescribing information, please visit, call 1-888-440-7903 or contact your health care provider.

Important Safety Information

CONCERTA(R) should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in CONCERTA(R); glaucoma; Tourette's syndrome, tics or family history of Tourette's syndrome. Abuse of methylphenidate may lead to dependence. Tell your health care professional if your child has had problems with alcohol or drugs, has had depression, abnormal thoughts or visions, bipolar disorder, seizures, high blood pressure or has had any heart problems or defects. If your child develops abnormal thinking or hallucinations, abnormal, extreme moods and/or excessive activity, or if aggressive behavior or hostility develops or worsens while taking CONCERTA(R), consult your health care professional. The most common adverse events reported in children receiving up to 54 mg were headache, upper respiratory tract infection and abdominal pain. The most common adverse events reported by adolescents receiving up to 72 mg were headache, accidental injury and insomnia.

About McNeil Pediatrics

McNeil Pediatrics Division of McNeil-PPC, Inc. is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics markets CONCERTA(R) OROS(R) methylphenidate HCL for treatment of children and adolescents with ADHD in the US. McNeil Pediatrics is continuing to explore other new therapies to meet the special needs of children and the pediatric community. Visit for more information.

CONCERTA(R) and OROS(R) are registered trademarks of ALZA Corporation. (a) Three patients not meeting study inclusion/exclusion criteria were

randomized to CONCERTA but did not receive study medication and were

not included in the analysis.


Media Investors

Tricia Geoghegan: (609) 462-8764 Louise Mehrotra: (732) 524-6491

McNeil Pediatrics Johnson & Johnson

Lesley Fishman: (732) 524-3922

Johnson & Johnson

SOURCE McNeil Pediatrics
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
8. Protox Announces Positive Clinical Data from Prostate Cancer Study
9. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
10. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
11. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
Post Your Comments:
(Date:11/24/2015)... , November 25, 2015 The ... to repeated failure of IVF cycles. After failure of ... dejected and had lost all hopes that she would be able to ... miracle child conceived after failure of over 15 IVF ... (UK) before they decided to take one last attempt with Gaudium ...
(Date:11/24/2015)... CARLOS, Calif. , Nov. 24, 2015 ... a leader in non-invasive genetic testing and ... announced that it will present at the ... in New York on Wednesday, December 2, 2015 at 1:00 p.m. ET.  Matthew ... the Company,s financial results, business activities and ...
(Date:11/24/2015)... TX and VANCOUVER, Nov. 24, 2015 /PRNewswire/ - ... NASDAQ: EPIX ) announced today that the first ... study of EPI-506 as a treatment for metastatic castration-resistant ... and Canada.  --> ... --> In the Phase 1/2 clinical trial, ESSA ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Today, Mothers Against Drunk ... roadways has dropped below 10,000 for the first time since 2011. In 2014, there ... According to data released by the National Highway Traffic Safety Administration (NHTSA), 32,675 people ...
(Date:11/25/2015)... ... ... An unlikely combination of recycled plastic shopping bags in ... to have a more dignified and comfortable night’s sleep. , Residents of Friendship ... bags into sleeping mats for the homeless. The project, according to Jeannette ...
(Date:11/25/2015)... CA (PRWEB) , ... November 25, 2015 , ... ... bunion treatment, is offering lower prices in an early celebration of the early ... the promotional price of $29.95 each (normally $33.95 ea). Black Friday promotional pricing ...
(Date:11/24/2015)... ... November 24, 2015 , ... Young patients with a wide variety ... Wolfman and Dr. Kedar S. Lele, who are pediatric dentists in Tucson, AZ ... the WaterLase iPlus 2.0™ system causes minimal discomfort and bleeding to the patient during ...
(Date:11/24/2015)... ... , ... DMG Productions announced that they will feature Aphria, Inc., in an ... Channel. Dates and show times TBA. , Aphria, Inc., is a publicly traded company ... and supplying medical marijuana pursuant to the Marijuana for Medical Purposes Regulations (the “MMPR”). ...
Breaking Medicine News(10 mins):