Navigation Links
New study of Concerta showed significant improvement of ADHD symptom management in adults
Date:10/26/2007

Boston, Mass., Friday Oct. 26, 2007 11:00AM Adults with Attention Deficit Hyperactivity Disorder (ADHD) treated with CONCERTA OROS 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 studys medical director, Sally Berry, M.D., PhD., of Johnson & Johnson Pharmaceutical Research and Development, LLC. Were encouraged that the CONCERTA findings presented today -- in which CONCERTA 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 to treat adults with ADHD. CONCERTA 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 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 group vs. -6.8 1.06 for the placebo group.

In addition, CONCERTA 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 36-108 mg/day or placebo, for seven weeks. The final analysis set contained data from 226 patients . Patients in the CONCERTA 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 group compared with 74 (63.8%) in the placebo group. The most commonly reported adverse events with CONCERTA 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 and placebo groups, respectively, discontinued due to adverse events.

Todays 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 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.


'/>"/>

Contact: Tricia Geoghegan
tgeogheg@janus.jnj.com
609-462-8764
Golin/Harris International
Source:Eurekalert

Related medicine news :

1. Rural Canadians travel far for specialists: study
2. A new study surpasses Gene Therapy Hurdle
3. Tomato Sauce reduces Cancer Risk- Study
4. A question on study of Adult Stem Cell
5. Study on obesity and heart failure
6. National Lung Study in the process
7. Marijuana gateway theory strengthened by study of twins
8. Old theory of adaptation confirmed by new study
9. Study casts doubt on keyboard ills
10. Gene study links endometriosis, infertility
11. Study reveals how stress can make you sick
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association ... Featuring a collection of specialty vendors and unique items from across the nation, this ... health and wellness services offered by the VNA. The boutique will be open ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... , ... “The Journey: From the Mountains to the Mission Field”: the story ... the Philippines. “The Journey: From the Mountains to the Mission Field” is the creation ... has taught all ages and currently teaches a class of ladies at her church, ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), ... of an innovative new design of the shoulder pad. The shoulder pad provides ... while controlling your pain while using cold therapy. By utilizing ice and water that ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017   Montrium , an ... solutions, today—from the IQPC Trial Master Files & ... NL)—announced that EastHORN Clinical Services has selected ... and TMF management. EastHORN, a leading European contract ... to increase transparency to enable greater collaboration with ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/18/2017)... PROVIDENCE, R.I. , Sept. 18, 2017 ... in the fields of bioinformatics and immune ... to develop a protective avian influenza A (H7N9) vaccine. ... is distantly related to seasonal influenza and ... approaches, which rely on prior exposure to be ...
Breaking Medicine Technology: