FT. WASHINGTON, Pa., March 20 /PRNewswire/ -- Specialty Pharmaceuticals Division of McNeil PPC, Inc., the marketer of CONCERTA(R) (methylphenidate HCl) Extended-release Tablets, is making available today data that the company has submitted to the U.S. Food and Drug Administration (FDA) in preparation for the Agency's upcoming Pediatric Advisory Committee meeting, which is scheduled to take place on March 22, 2006. The briefing document is now available at http://www.concerta.net.
"Specialty Pharmaceuticals is committed to ensuring that physicians and patients have the most complete and accurate information available about the medications that we market," says Patrick E. Ciccone, MD, Vice President, Medical Affairs, Specialty Pharmaceuticals Division of McNeil PPC, Inc. "We recognize that patients, physicians and regulatory authorities are extremely interested in the current discussions about ADHD medications and the outcome of the upcoming Pediatric Advisory Committee meeting. We also know that medications such as CONCERTA(R) have made a significant impact in improving the lives of patients with ADHD and their families. It is our hope that, by making this information available in advance of the meeting, we will enable prescribing physicians to have ample opportunity to evaluate the data and place it in proper context when having treatment discussions with their patients."
As part of the analysis that Specialty Pharmaceuticals submitted to the FDA, the company specifically evaluated the benefit-risk ratio of therapy with CONCERTA(R). CONCERTA(R) is the most commonly prescribed medication for treating and managing ADHD among children and adolescents. Clinical trials have shown the effectiveness of CONCERTA(R) in improving the symptoms of ADHD in children include reducing off-task behavior and gross motor hyperactivity, improving compliance with supervising adults, and reducing aggressiveness. In addition, children treated with CONCERTA(R) show positive outcomes in social behavior, academic performance and cognitive functioning.
The company, with the assistance of external investigators, also evaluated the risk of potentially serious side effects such as cardiovascular events, suicidal behavior, psychosis and mania. With regard to cardiovascular events, the analysis showed the rate of sudden cardiac death was estimated to be 0.19 per 100,000 patient-years with methylphenidate. The rate of sudden cardiac death in children and young adults in the general population is approximately 1.3 to 8.5 per 100,000 persons. Therefore, even with a correction for under-reporting, the observed rate of sudden death in patients receiving methylphenidate is consistent with the rate of sudden death in the general population.
Regarding psychiatric events, a post-marketing safety review for CONCERTA(R) included patients reporting suicidality. These reports may be confounded by the possible existence of additional serious psychiatric conditions in some patients with ADHD and the prevalence of suicidal behaviors in the general adolescent population. Based on CONCERTA spontaneous reports, the rate of suicidal ideation, or the thought of attempting suicide, which represents the largest element of suicidality, was calculated to be 0.65 cases per 100,000 patient-years. Again, even with a correction for under-reporting, the observed rate of suicidal ideation is lower than the rate of suicidal ideation in the general population. The rates of reported psychosis and mania are also low compared to the total number of methylphenidate prescriptions.
"When evaluating the benefit-risk ratio of ADHD medications, it is important to remember that untreated ADHD is associated with severe consequences," Dr. Ciccone says. "Therefore it is important to address some of the inaccuracies surrounding this disorder and focus on the facts. We look forward to continuing to work with the FDA to ensure important safety information is appropriately communicated to prescribing physicians and patients who use ADHD medications."
Important Safety Information
CONCERTA should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA; glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Children under 6 years of age should not take CONCERTA. Abuse of methylphenidate may lead to dependence.
CONCERTA should not be used to treat normal fatigue or severe depression. Use with caution in patients with psychosis, history of seizures/EEG abnormalities, and hypertension. CONCERTA should not be used in patients with pre-existing severe gastrointestinal narrowing or known structural cardiac abnormalities. Methylphenidate may produce difficulties with accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy.
The most common adverse events reported in children aged 6 to 12 years receiving up to 54 mg were headache (14%), upper respiratory tract infection (8%), abdominal pain (7%).
The most common adverse events reported in adolescents receiving up to 72 mg were headache (9%), accidental injury (6%), and insomnia (5%).
CONCERTA(R) is marketed in the U.S. by Specialty Pharmaceuticals Division of McNeil PPC, Inc. For more information about CONCERTA(R), including full U.S. prescribing information, please visit http://www.concerta.net/ or call 1-888-440-7903.
Specialty Pharmaceuticals Division of McNeil PPC, Inc.