Drugs Approved by the FDA
Drug Name: Metadate CD
The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.
Company: Celltech Pharmaceuticals
Approval Status: Approved April 2001
Treatment for: Attention Deficit Hyperactivity Disorder
General Information
Metadate CD, a once-daily biphasic formulation of methylphenidate, has been approved for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years of age and older.
The biphasic release profile of Metadate CD capsules, provided by Eurand's novel Diffucaps technology, delivers an initial rapid release of methylphenidate followed by a second continuous release phase. This once-daily regimen effectively controls ADHD symptoms during the school-day, when need is greatest, without the inconvenience and embarassment of a school-day dose.
ADHD is a behavioral disorder with symptoms that include developmentally inappropriate levels of attention, concentration, activity, and impulsivity. One of the most common psychiatric disorders in children and adolescents, ADHD often persists into adulthood. The disorder affects three to five percent of all school-aged children.
Clinical Results
Metadate CD was evaluated in a randomized, double-blind, parallel-group, placebo-controlled trial in 32 centers. Over 300 children between the ages of six and 15, all previously diagnosed with ADHD, were involved. The study was comprised of a one-week, single-blind, placebo run-in and a three-week, double-blind titration and treatment period. Metadate CD was given in individually titrated doses of 20, 40, or 60 mg.
The efficacy of Metadate CD capsules was measured by the difference from baseline on the teacher's version of the Connors' Global Index Scale (TCGIS), which assesses 10 aspects of behavior and monitors treatment effectiveness and changes over time. Mean improvement from baseline on the TCGIS was significantly greater for Metadate CD compared with placebo.
Side Effects
Adverse events associated with the use of Metadate CD capsules may include (but are not limited to) the following:
Headache
Loss of appetite
Abdominal pain
Insomnia
Mechanism of Action
Metadate CD (methylphenidate hydrochloride) utilizes Eurand's novel Diffucaps technology, which provides a biphasic release profile suitable for once-daily dosing. Metadate CD capsules contain methylphenidate in both rapid release and continuous release beads such that 30 percent of the dose is rapidly released with the remainder being continuously released.
Additional Information
For additional information on Metadate CD, please visit Celltech.
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Drug listing last updated on May 15, 2001
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