March 19, 2006 at 10:09:51

Just What Kids Need - Sparlon - Another ADHD Drug

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By Evelyn Pringle (about the author) Page 2 of 3 page(s)

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In addition, he notes, with regard to potential conflicts of interest, itemized conflicts for each of the Pediatric study's authors are numerous.

For instance, Dr. Biederman received research support from 10 companies, serves on speakers' bureaus for 4 companies, and is on advisory boards of 6 companies, Dr Dubose Ravenel reveals.

Dr. Kratochvil, he advises, has received research support from, served as a consultant for, and/or served on speakers' bureaus for 10 pharmaceutical companies.

Other authors have numerous listed conflicts as well he notes.

In light of recent widely publicized articles showing widespread deceptive practices engaged in by pharmaceutical companies in designing, selective reporting, and interpreting studies, he says, the large number of pharmaceutical company ties with the authors of the study do not lend confidence to the reader even beyond the aforementioned concerns.

Initial marketing of modafinil, Dr Dubose Ravenel concludes, as a drug for treating ADHD reveals inaccurate and exaggerated claims concerning efficacy, safety, and the mechanism of action by which the drug works.

And come to find out, it seems Sparlon is not so "well-tolerated" after all. Last week the FDA announced that an analysis provided by Cephalon as part of its response to the FDA's approvable letter found 4 suicidal events, 2 events of psychosis/mania and 9 aggression events in the double blind clinical studies of Sparlon, in a summary report for the Pediatric Advisory Committee.

In addition, two events of psychosis/mania and 14 aggression events were seen in open-label studies of modafinil for ADHD, the FDA said. These rates are compared to 5 aggression events and no suicidal or psychosis/mania events in placebo patients from the double-blind trials.

There were more events in all categories among modafinil treatment patients compared to placebo, but the exposure to modafinil was greater, the FDA said.

It will be noted, however, that the frequency of these events during double-blind treatment was higher than during open-label treatment, the FDA said.

The FDA summary also pointed out that two additional probable cases of aggression during double-blind treatment, in study 207, were found by the agency's Psychiatry Products Division.

A March 3, 2006, memorandum to various FDA's divisions on drug safety, from FDA official Andrew Mosholder, noted that psychosis/mania events occurred during double-blind treatment with every ADHD drug studied except Adderall XR.

With respect to psychosis and mania events, the memorandum wrote, although the numbers of such events with drug treatment were small, the complete absence of such
events with placebo treatment was notable.

The memorandum also noted that suicidal events were found to be more frequent with modafinil treatment than with placebo.

At a hearing last month on February 9, 2006, Dr Mosholder, told the FDA's Drug Safety Advisory Committee that modafinil, marketed as Provigil, is a stimulant. He said modafinil is a different type of stimulant, marketed for excessive sleepiness associated with various sleep disorders.

It too may have some cardiovascular effects, Dr Mosholder told the panel. There was a finding that use of antihypertensives during the clinical trials was more frequent than on placebo, which suggests that there are some cardiovascular effects there as well.

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