If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  FDA Approves Metadate (Methylphenidate) Extended Release For Attention Deficit Hyperactivity Disorder ROCHESTER, NY -- April 4, 2001 -- Celltech Pharmaceuticals, Inc. (formerly Medeva Pharmaceuticals, Inc.), a member of the Celltech Group announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Metadate® CD (methylphenidate HCl, USP) Extended-Release Capsules, 20 mg, a once-daily biphasic formulation of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years of age and older. The biphasic release profile of Metadate CD provides an initial rapid release of methylphenidate, followed by a second continuous release phase, resulting in school-day-long control of ADHD symptoms. In clinical trials, Metadate CD did not interfere with evening appetite or sleep in the majority of patients. Metadate CD utilizes Eurand's novel Diffucaps® technology, which provides the biphasic release profile suitable for once-daily dosing. "Metadate CD Capsules improve symptoms of ADHD for a full school-day," said Laurence Greenhill, M.D., a psychiatrist at New York State Psychiatric Institute and lead investigator of the Metadate CD multi-center study. "For school-age children, a morning dose of Metadate CD effectively controls inattentiveness, disruptive behavior and other symptoms of ADHD during the school-day, when the need for control is greatest. The once-daily regimen also eliminates the inconvenience and embarrassment of a school-day dose." "Metadate CD exerts a treatment effect both in the morning and in the afternoon, when it is needed most, and offers the convenience of once-daily dosing in a way that doesn't come at the expense of a child's lifestyle," said Dr Michael Tidd, Vice President of Medical Affairs, Celltech Pharmaceuticals, Inc. Metadate CD: proven efficacy for control throughout the school-day Three hundred and fourteen children with ADHD between the ages of six and 15 were evaluated in a randomized, double-blind, parallel-group, placebo-controlled, 32-center study. The study was comprised of a one-week, single-blind, placebo run-in and a three-week, double-blind titration and treatment period. The treatment schedule included Metadate CD capsules given in individually titrated doses of 20, 40 or 60 mg daily or matching placebo. The primary objective of the study was to compare the efficacy, safety and tolerability of once-daily (before school) administration of Metadate CD capsules with placebo, in children with a confirmed diagnosis of ADHD. The primary efficacy measure was the difference from baseline on the teacher's version of the Conners' Global Index Scale (TCGIS). The TCGIS assesses 10 different aspects of behavior and monitors treatment effectiveness and changes over time. The measurement was completed in the morning and afternoon during each week of treatment. Patients' average scores during the last week of treatment were used in the primary efficacy outcome assessment. The calculated mean improvement from baseline on the TCGIS was significantly greater for Metadate CD capsules compared with placebo (7.9 vs 1.2, respectively). Additionally, comparative analyses showed clinically and statistically significant improvement compared with placebo (p<.001) in both the morning and afternoon. The most common adverse reactions demonstrated in clinical trials were headache (12 percent), loss of appetite (9 percent), abdominal pain (7 percent) and insomnia (5 percent). In a pharmacokinetic study, Metadate CD demonstrated an initial peak plasma level at about 1.5 hours and a second peak at about 4.5 hours. The biphasic release of medication provided school-day-long control of ADHD symptoms. Eurand's Diffucaps technology provides customized release profiles for optimal therapeutic results. The technology is a multi-particulate system in which individual beads of the drug are prepared with specific rate-controlling membranes providing a unique release profile. Customized release profiles, designed to provide optimal clinical benefit, can then be achieved by combining different types of beads into each capsule. Metadate CD Capsules contain methylphenidate in both rapid release and continuous release beads such that 30 percent of the dose is rapidly released and 70 percent of the dose is continuously released. Metadate CD is available in a dose pack of 30 blister-sealed capsules. This distinctive packaging helps parents and other caregivers keep track of remaining doses. In addition, the dose pack contains patient information and space for parents to note when a dose of Metadate CD was given. Metadate CD should not be used in children under six years of age. Metadate CD Capsules are contraindicated in patients with marked anxiety, tension, and/or agitation since the drug may aggravate these symptoms. Metadate CD Capsules should not be used in patients with glaucoma, motor tics, or a family history or Tourette's Syndrome, and during or within 14 days of treatment with MAO inhibitors. Metadate CD Capsules should be used with caution in patients with a history of psychosis, drug dependence, or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence. Caution is advised when Metadate CD is prescribed for patients with a history of seizures. Hypertension or cardiovascular disease, and in those who are receiving anticoagulants. Anticonvulsants, some antidepressants (tricyclics, SSRI's), and pressor agents. SOURCE Celltech Pharmaceuticals, Inc.
|
