US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
EAST HANOVER, N.J., Nov. 12 /PRNewswire/ — The US Food and Drug Administration (FDA) has approved a 30-minute onset of action for Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.
“The morning is a critical time for families,” said Alice Mao, MD, Associate Professor of Psychiatry at the Baylor College of Medicine. “The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine.”
The new labeling is based on clinical study data. The most recent study, involving 86 children with ADHD between the ages of six and 12, showed that Focalin XR provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment, and academic productivity.
ADHD affects approximately three to six percent of children in the United States, and its symptoms – inattention, hyperactivity and impulsivity – can significantly impact a child’s ability to focus and behave in school.
A 2007 Harris survey of 1,001 caregivers of young ADHD patients revealed that caregivers were significantly more likely to report that their child’s or adolescent’s behavior was negatively affected in the morning compared to other periods through the day in 12 out of 16 common behaviors. These negative behaviors included lack of concentration, messiness, interrupting others, failure to complete tasks and speaking out of turn.
“The 30-minute onset of action can help children with ADHD improve their morning academic productivity in school. Focalin XR also allows them to effectively manage their symptoms for up to 12 hours getting them through school and homework time,” said Rafael Muniz, MD, Senior Medical Director, Novartis Pharmaceuticals Corporation.
The data for 30-minute post-dose labeling includes a study by Brams et al. recently published in CNS Drugs. The study was a randomized, multi-center, double-blind crossover study in which participants received 20 mg of Focalin XR or placebo for seven days, with the final dose administrated in a laboratory classroom setting on the last day of each treatment period.
Primary efficacy was measured by the change from pre-dose in the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined score at 0.5 hours, with additional secondary assessments at 1, 2, 4, 6 and 8 hours post-dose. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior.
Secondary efficacy was measured by the change from pre-dose at all time points in SKAMP-Attention and -Deportment, Math test-Attempted and -Correct scores, and change from baseline on the Conners’ ADHD/DSM-IV Scale for Parents (CADS-P).
The overall rate of adverse events (AEs) was similar between groups (17.4% Focalin XR vs. 22.1% placebo). The most common AEs (>/= 2% patients during double-blind treatment) were abdominal pain, headache, increased appetite, and viral gastroenteritis. Most AEs were reported as mild (15% Focalin XR; 17% placebo) or moderate (1% Focalin XR; 5% placebo) in severity. One patient experienced a headache reported as severe while receiving Focalin XR. There were no serious AEs reported or discontinuations due to AEs.
Focalin XR (dexmethylphenidate HCl) extended-release capsules are indicated for the treatment of ADHD in adults, adolescents and children six years and older. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (e.g., psychological, educational and social).
Important Safety Information
The most common adverse events seen with Focalin XR were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.
Focalin XR is contraindicated in patients with marked anxiety, tension and agitation since the drug may aggravate these symptoms; in patients known to be hypersensitive to methylphenidate or other components of the product; in patients with glaucoma; in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome; and during or following treatment with monoamine oxidase inhibitors.
Stimulants should generally not be used in children, adolescents or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart-rhythm abnormalities or other serious cardiac problems. Use with caution in treating patients with underlying medical conditions that might be compromised by increases in blood pressure or heart rate, such as those with pre-existing hypertension, heart failure, recent myocardial infarction or ventricular arrhythmia. Before initiating treatment, patients should have careful history and physical exam to assess for presence of cardiac disease.
Use with caution in psychosis or bipolar disorder. Discontinuation of treatment may be appropriate in the presence of treatment-emergent psychotic or manic symptoms. While aggressive behavior is often observed in children or adolescents with ADHD, patients beginning treatment should be monitored for the appearance of or worsening of aggressive behavior or hostility.
Suppression of growth has been reported with long-term use of stimulants. Stimulants should be used with caution in patients with a prior history of seizures or EEG abnormalities. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (See WARNINGS.)
Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Please see full Prescribing Information for Focalin XR including Contraindications, Boxed Warning and Medication Guide at http://www.focalinxr.com/ or call us at 1-888-NOW-NOVA.
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Celgene Corporation of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin XR in the U.S.
Focalin XR was developed with SODAS(R) technology (spheroidal oral drug absorption system), a multiparticulate drug delivery system of Elan Corporation, plc . Focalin XR is being supplied to Novartis under an exclusive worldwide (except Canada) royalty and manufacturing agreement between Elan Corporation, plc, and Novartis Pharma AG.
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