In fact, the 2004 PDR raises specific concerns about modafinil, saying that it can produce "psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants," he wrote.
The PDR also states that "modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine," Kruszewski noted.
He pointed out that the comment on the lack of euphorigenic effects was also contradicted by the FDA in a January 14, 2002, warning letter sent to Paul Kirsch, the senior director of regulatory affairs at Cephalon, which specifically reiterates the drug's package insert addressing the modafinil's euphorigenic effects and its potential for abuse.
The implications loomed even larger, he said, because Cephalon had submitted a "reformulated" modafinil to the FDA under a new name for the treatment of children and adolescents with attention deficit hyperactivity disorder.
The second example of the debate, was a June 2007 Letter to the Editor, of the Journal of Clinical Psychiatry, from Dr Kruszewski and Dr Steven Klotz, in response to an article published in an August 2006 supplement to the Journal titled, "New Developments in the Treatment of Attention-Deficit/ Hyperactivity Disorder," by Dr Joseph Biederman, Chief of Pediatric Psychopharmacology at Massachusetts General Hospital and Professor of Psychiatry at Harvard Medical School.
The supplement was underwritten by an educational grant from Cephalon.
In his article, Biederman stated: "The pharmacologic profile and structure of modafinil are notably different from those of stimulants and other agents used to treat ADHD, and modafinil may reduce the core symptoms of ADHD via the same mechanism by which it improves wakefulness--selective activation of the cortex without generalized effects on the central nervous system."
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