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The FDA has approved lisdexamfetamine dimesylate (Vyvanse) to treat attention deficit/hyperactivity disorder in adults, the manufacturer announced on Wednesday.
In a 4-week, placebo-controlled trial of some 400 adults with ADHD, those taking once-daily Vyvanse achieved better control of ADHD symptoms within 1 week.
Vyvanse, a therapeutically inactive prodrug made up of d-amphetamine covalently bonded to l-lysine, is converted to active d-amphetamine after ingestion. It's a Schedule II controlled substance, with side effects similar to those of other amphetamines, including decreased appetite, trouble falling asleep, and cardiac and psychiatric problems.
The drug was approved for use in children aged 6 to 12 years in 2007.
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LINK(S):
Manufacturer press release (Free)
Vyvanse prescribing information (Free PDF)
Physician's First Watch coverage of drug's initial approval (Free)