Vyvanse is as a new ADHD medication designed to provide lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d-amphetamine, which is responsible for the drugs activity.
In clinical studies designed to measure duration of effect, Vyvanse provided significant efficacy compared to placebo for a full treatment day.
Furthermore, when Vyvanse was administered orally and intravenously in two clinical human drug abuse studies, Vyvanse produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.
“The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of Vyvanse which illustrate benefits that differentiate this compound from other ADHD medicines,” said Matthew Emmens, Shire CEO.
Shire is hoping that Vyvanse will become a successor to its blockbuster treatment Adderall, and has recently agreed to buy New River to take full control of the drug’s development.
The FDA has proposed that Vyvanse be classified as a schedule II controlled substance. The product launch is anticipated in the second quarter 2007.