"This study not only shows that this medication is effective and rapid in onset for the treatment of pediatric ADHD," Biederman said in the presentation. "It also gives the clear signal that here we have a medication that can be used by physicians to treat ADHD in children who cannot tolerate amphetamine salts or for whom the clinician simply prefers not to use amphetamine salts."
Another study, in the December 2005, "Pediatrics" journal, with lead investigator Biederman, said Sparlon's effectiveness and safety profile, along with its low potential for abuse, may offer doctors and parents a new option for children with ADHD. At that time, Biederman's disclosures showed he received research funding from ten drug companies, served on the speaker's bureau of four, and sat on advisory boards of six.
In applying for FDA approval, Cephalon submitted three trials of Sparlon on less than 700 children. According to a report by FDA reviewer Andrew Mosholder, "two kids experienced psychotic or manic episodes; four kids considered suicide; and nine kids engaged in serious "aggression events" in the modafinil trials," Merrill Goozner reported in GoozNews on March 20, 2006.
"That was the equivalent of 20 negative reactions for every 100 patients who take the drug for a year," Goozner said. "Only Adderall and a skin patch had a worse record."
In the end, an FDA Advisory Committee determined that Sparlon was not safe enough to be marketed to kids, by a vote of 12 to 1, in March 2006, and in August 2006, Cephalon reported that the FDA had rejected the drug for children and the company decided to end development of Sparlon.
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