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Back To Vidyya Results Of Phase III Study Evaluating A New Once-Daily Treatment For ADHD Anncounced

Data Presented At The American Academy Of Child And Adolescent Psychiatry (AACAP) Annual Meeting

Medeva Pharmaceuticals has reported that results from a Phase III clinical trial of a modified release formulation of methylphenidate hydrochloride for the treatment of attention deficit hyperactivity disorder (ADHD) were presented in abstract form at the 47th annual American Academy of Child and Adolescent Psychiatry (AACAP) meeting in New York City.

Methylphenidate modified release capsules, which are currently under review for marketing approval by the U.S. Food and Drug Administration (FDA), includes a new and unique biphasic release profile which is designed to eliminate the need for a school day dose. Methylphenidate modified release capsules utilize Eurand's novel Diffucaps(R) technology, a multi-particulate bead delivery system with each bead acting as a drug reservoir. Each bead is coated with a carefully chosen polymer to provide a unique release profile. Customized release profiles can then be achieved by incorporating different types of beads into each capsule. Methylphenidate modified release capsules contain immediate-release and extended-release beads in a ratio of 30 to 70.

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. Methylphenidate modified release capsules were given in individually titrated doses of 20, 40 or 60 mg daily with matching placebo. The primary objective of the study was to compare the efficacy, safety and tolerability of once daily (before school) administration of methylphenidate modified release capsules with placebo in children with a confirmed diagnosis of ADHD.

"The results of this trial demonstrate that methylphenidate modified release capsules given once daily before school, were shown to control the symptoms of ADHD throughout the school day without the need for a second midday dose," said Laurence Greenhill, M.D., a psychiatrist at New York State Psychiatric Institute and lead investigator of this multi-center study.

The primary efficacy measure was the difference from baseline on the teacher's version of the Conners' Global Index (CGI). The CGI assesses 10 different levels of behavior and monitors treatment effectiveness and changes over time. This measurement was completed in the morning and afternoon during the last week of treatment. The estimated mean improvement from baseline on the teacher's CGI was 7.9 for methylphenidate modified release capsules compared to 1.2 for placebo (p less than .001). Additionally, specific comparative analysis showed improvement versus placebo was equally good in the morning and afternoon (p less than .001).

In the study, once daily methylphenidate modified release capsules had a safety profile similar to other methylphenidate products. The most common adverse events compared to placebo were headache, abdominal pain, anorexia, and insomnia.

Facts About ADHD

  • -- Attention Deficit Hyperactivity Disorder (ADHD) is a behavioral disorder with symptoms that include developmentally inappropriate levels of attention, concentration, activity, distractibility and impulsivity.(1) It is one of the most common psychiatric disorders of childhood and adolescence and often persists into adulthood.(2)
  • -- ADHD affects approximately three to five percent of school-aged children.(3)
  • -- ADHD has been shown to have long-term adverse effects on academic performance, vocational success and social-emotional development.(1)

Medeva Pharmaceuticals, Inc. is the pharmaceutical marketing arm of UK-based Celltech Group, an international R&D leader in antibody technology with extensive medicinal chemistry as well as biopharmaceutical development expertise. Medeva's U.S. operations are headquartered in Rochester, NY. Medeva develops, manufactures, and markets prescription pharmaceuticals worldwide. Areas of therapeutic focus include ADHD; liquid extended release cough and cold products; diuretics for edema due to congestive heart failure and hypertension; and a variety of niche products in allergy, respiratory, weight loss and bladder cancer.

Eurand is an independent, multinational, oral drug delivery company dedicated to providing the pharmaceutical industry with solutions to the most challenging drug delivery problems. Eurand's extensive portfolio of proprietary technologies provides a number of options to improve the therapeutic performance of drugs and includes systems designed for enhanced bioavailability, rapid onset of action, improved absorption, oral peptide delivery, customized release, region specific drug delivery, taste masking and quick dissolving formulations. Eurand has recently launched its newest technology, Biorise, which is designed to enhance the bioavailability and improve the onset of action of poorly soluble drugs. Eurand is a fully integrated drug delivery company offering a complete range of development, scale up and commercial manufacturing capabilities in both Europe and the USA.

  • (1) Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder. NIH Consens Statement 1998 Nov. 16-18; 16(2) p 3, 4, 8: In press.
  • (2) Dulcan, M. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 1997; 36;10: 101S.
  • (3) Diagnostic and Statistical Manual of Mental Disorders, 4th ed. DSM-IV. Washington, D.C.: American Psychiatric Association, 1994, pg 82.

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Editor: Susan K. Boyer, RN
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