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| |  Once-Daily Concerta (Methylphenidate) For Attention Deficit Hyperactivity Disorder Approved In US MOUNTAIN VIEW, CA -- August 2, 2000 -- Alza Corporation announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market Concerta™ (methylphenidate HCl) extended-release tablets (CII) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six and older. Developed on behalf of Crescendo Pharmaceuticals Corporation, Concerta is expected to be available by prescription before the start of the 2000 school year. Until Concerta, there was no once-daily methylphenidate medication for ADHD that worked effectively throughout the day. Some other forms of medication may require two or three doses per day to achieve the desired improvement in symptoms. Concerta uses an advanced Oros® patterned-release delivery system. The Oros system has been used safely for nearly 20 years in widely accepted prescription and over-the-counter medications, including medications taken by children. "For patients taking Concerta, the need for in-school and after-school dosing will be eliminated," said Timothy E. Wilens, M.D., Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital. "That's especially important for kids with after-school activities and homework. Using this once-a-day medication for ADHD can also help to eliminate the feelings of embarrassment that children may have when taking medication in the middle of the school day or during after-school activities." "When Max was first diagnosed with ADHD and put on medication, we noticed an immediate improvement in his symptoms," said Francine Padrid, mother of a 13-year old boy enrolled in the clinical trial. "The problem was he had to take the medication several times a day. With Concerta, he only has to take it once in the morning. That's great because he doesn't have to take his medication at school or hurry home after school." "This is a very exciting time for all the employees of Alza, who have worked for many years to fill an important need in the treatment of ADHD," said Dr. Ernest Mario, Chairman and C.E.O. of Alza Corporation. "Alza, in partnership with McNeil Consumer Healthcare, is committed to responsibly educating parents, physicians, and other health care professionals about the importance of properly diagnosing and treating ADHD and the role of Concerta as part of a total treatment program." The efficacy of Concerta was evaluated in three double-blind, active- and placebo-controlled studies of 416 children from the ages of six through 12. The product was evaluated in multiple settings -- including community schools, laboratory schools (specialized schools used to monitor children with ADHD for treatment evaluation purposes), and at home. Concerta qd (18, 36, or 54 mg) was compared to methylphenidate given tid (15, 30, or 45 mg total daily dose) over 12 hours and placebo in three double-blind trials in patients aged six to 12 years old. In these three studies, teachers and parents consistently reported a statistically significant improvement in attention and reduction in overactivity throughout the day among children taking once-daily Concerta versus placebo. Both teachers and parents used the IOWA Conners scale, one of the most commonly used and recognized scales for evaluating children with ADHD in clinical studies. The IOWA Conners scales rate inattention and overactivity on a scale from one to 15, with lower numbers representing improved behavior. In one of the three studies, a large-scale 13-center trial including 282 children between the ages of six and 12, community teachers using the IOWA Conners scale rated children an average of 5.98 for Concerta and 9.77 for placebo. Concerta employs an advanced form of Alza's Oros technology, which uses osmotic pressure to deliver medication at a controlled rate. This technology features a semipermeable rate-controlling membrane surrounding an osmotic core, which contains a push layer and a drug layer. Once in the body's gastrointestinal tract, water enters the osmotic system and dissolves or suspends the drug in the tablet's core. The drug is then released through a laser-drilled hole in the membrane at a controlled rate. This can be a significant benefit for patients by providing controlled symptom relief and reducing the number of daily doses compared to conventional therapies. "The advantage of Concerta is that the outer layer of medication provides an immediate release of methylphenidate within one hour, while the inner layers provide medication to sustain effect through the school day and into the early evening," said James M. Swanson, PhD., director of the Child Development Center and professor of Pediatrics and Cognitive Sciences, University of California, Irvine. "This system provides smooth drug levels throughout the day that minimizes the peak and trough blood fluctuations associated with repeated dosing of immediate release MPH products." Concerta is available in 18 mg and 36 mg tablets. It should be taken in the morning, with or without breakfast. Concerta tablets must be swallowed whole with the aid of liquid and must not be chewed, divided, or crushed. In the largest controlled clinical study with patients using Concerta, the most common side effects reported were headache (14 percent), upper respiratory tract infection (8 percent), stomach ache (7 percent), vomiting (4 percent), loss of appetite (4 percent), sleeplessness (4 percent), increased cough (4 percent), sore throat (4 percent), sinusitis (3 percent), and dizziness (2 percent). Concerta should not be taken by patients who: have significant anxiety, tension, or agitation, since Concerta may make these conditions worse; are allergic to methylphenidate or any of the other ingredients in Concerta; have glaucoma, an eye disease; have tics or Tourette's syndrome, or a family history of Tourette's syndrome; or who are taking a prescription monoamine oxidase inhibitor (MAOI). Concerta 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. Concerta should not be used in children under 6 years, since safety and efficacy in this age group have not been established. Concerta should not be administered to patients with preexisting severe gastrointestinal narrowing. ADHD is a medical condition characterized by symptoms of inattention and/or hyperactivity-impulsivity that affects millions of children and adults, often having a significant impact on a person's life. According to the National Institutes of Health (NIH), ADHD is one of the most common mental disorders among children. Today, ADHD affects approximately three to five percent of the U.S. school-age population, with boys diagnosed three to four times more often than girls. Establishing a diagnosis of ADHD (according to the Diagnostic and Statistical Manual of the American Psychiatric Association) requires that symptoms of inattention and/or hyperactivity-impulsivity have persisted for at least six months and that they are more frequent and severe than typically seen in individuals at a comparable level of development. Some symptoms of ADHD must have been present before age seven, with some present in at least two settings (for instance, at school and at home). There must also be impairment from the symptoms in two or more settings (e.g. at school, work, and at home). While most people with ADHD have symptoms of both inattention and hyperactivity-impulsivity, one symptom pattern may predominate, resulting in three different subtypes: predominately hyperactive-impulsive type, predominately inattentive type, and combined type. Related Link: Alza Corporation.
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