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The drug Sparlon -- associated with 31 cases of increased suicide risk, aggression or psychosis during clinical trials for treatment of attention deficit hyperactivity disorder in children -- will be discussed March 22 at a meeting of the U.S. Food and Drug Administration's Pediatric Advisory Committee.
The following day, the FDA's Psychopharmacologic Drugs Advisory Committee will review a new drug application for Sparlon as a treatment for ADHD. The drug is currently marketed as a treatment for narcolepsy, under the name Provigil.
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A central issue in the committee's discussion is likely to be what warnings Sparlon must carry and how the non-stimulant drug will be distinguished from more traditional ADHD stimulant drugs, such as Adderall.
Last fall, the FDA issued an "approvable letter" for Sparlon as a treatment for ADHD.
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