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Adults with ADHD Respond Well to Once-Daily Multilayer-Release Formulation of Methylphenidate (Biphentin): Presented at AACAP

By Paula Moyer

TORONTO, CANADA -- October 31, 2005 -- Adults with attention deficit hyperactivity disorder (ADHD) respond well to a multilayer-release formulation of methylphenidate (Biphentin), according to investigators who presented findings here at the joint meeting of the American and Canadian Academies of Child and Adolescent Society (AACAP/CACAP).

"This formulation of methylphenidate produced significant improvement in ADHD symptoms and behavior for adults at home and at work or school," according to presenter Graeme Donnelly, MS, Clinical Research Scientist, Purdue Pharma, Pickering, Ontario, Canada, which manufactures Biphentin.

Dr. Donnelly noted that several study participants were university students. "This formulation may expand treatment options for adults with ADHD because of its convenience and tolerability, as well as its efficacy."

The investigators wanted to address a key therapeutic concern of adults with ADHD, who often express a desire for a treatment with a rapid onset of action, as with immediate-release methylphenidate (Ritalin), but yet a long duration of action so that patients can fulfill their responsibilities at work and at home.

In the randomized, double-blind, crossover trial, patients received no medication during the first week of the trial, after which they received a titrated dosage of methylphenidate multilayer release formulation for 1 to 3 weeks. After a maximal effect of the medication was achieved, patients received a stable dose of treatment for 2 weeks.

Among the original 50 patients, 39 completed the study, consisting of 23 men and 16 women who were an average of 37.9 years old. The investigators rated the effect of treatment with the Clinical Global Impressions (CGI) scale and the Connors Adult ADHD Rating Scales (CAARS-Self and CAARS-Observer), which they conducted at weekly visits.

Treatment with Biphentin significantly improved symptoms compared to placebo, as seen by CGI scores of 2.6 and 3.7, respectively (P = .0015). The improvement over baseline on the ADHD index on the CAARS-S was 12.2 points in the treatment group compared to 5.4 in the placebo group (P = .0083). The change on the same index on the CAARS-O trended to significance, a change of 10.9 in the treatment group compared to 6.8 in the placebo group (P = .14).

The most frequent adverse events were headache (26% and 24%), and anorexia (22% and 6%). Other adverse events included insomnia (20% and 4%), nervousness (20% and 4%), and nausea (16% and 8%). No serious adverse events occurred, the investigators reported.

Purdue Pharma sponsored the study.


[Presentation title: Double-blind, Placebo-Controlled, Crossover Study of Multiplayer-Release Methylphenidate in Adult ADHD. Abstract C-19]

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