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OROS(R) Methylphenidate in Adults with ADHD: New Insights
Date:5/7/2008

ndings from that study presented today, OROS(R) MPH demonstrated efficacy in the study population. Specifically, OROS(R) MPH demonstrated significant efficacy in adults with ADHD across the dose range studied (36 to 108 mg/day) and consistency in symptom evaluation between clinicians (using the Adult ADHD Investigator Symptom Rating Scale [AISRS]) and patients (using the Conners' Adult ADHD Rating Scale-Self Report, Short Version [CAARS-S:S]).

"What's important about these data is that patients and clinicians in this study showed clear agreement on how each viewed the severity of the condition being treated, as well as the patient response to the medication being tested," notes Joseph M. Palumbo, M.D., Franchise Medical Leader in Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD). "What we saw in patients' responses to treatment across the dose range studied suggest that adults with ADHD may benefit from more personalized treatment options."

Safety and Cardiovascular Data

Other findings presented today showed OROS(R) MPH to be well tolerated, with no unexpected cardiovascular effects associated with OROS(R) MPH in the study populations of the short-term dose-titration trial as well as the long-term, open-label trial. Consistent with Food and Drug Administration class labeling for all stimulant ADHD medication, which states that patients with serious cardiovascular illness should generally not be treated with stimulants, patients with a history of serious cardiovascular illness were excluded from both the short-term dose-titration study and the long-term open-label trial. Throughout both trials, heart rate and blood pressure were monitored during the titration period and the dose was reduced if certain cut-off heart rate or blood pressure values were reached. The long-term, open-label trial included an ECG every three months.

Final results from the open-label trial conducted for up to one year showed that in
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SOURCE McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen
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